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A COMPARATIVE EVALUATION OF DEXMEDETOMIDINE, PROPOFOL AND MIDAZOLAM FOR INTRAOPERATIVE SEDATION IN REGIONAL ANAESTHESIA.

BACKGROUND

Regional anaesthesia is popular and offers several benefits to the patient. The top three from the patient's point of view are staying awake, early family contact and early food intake. [5] This shows that patients are interested in postoperative landmarks [1,2] and their importance regarding patient's satisfaction. For the anaesthetist, cardiovascular and respiratory stability, rapid postoperative recovery and preservation of protective airway reflexes are the most important advantages of regional anaesthesia. Some drawbacks linked with regional anaesthetic techniques are pain at the puncture site, [1] fear of needles [3] and recall of the procedure. [4] These factors stress the importance of sedation that offers analgesia, anxiolysis and amnesia. Sedation is part of the general management of a patient receiving a regional block and being awake during the whole surgical procedure. The aims include general patient comfort, freedom from specific discomfort and some amnesia for both the block procedure and the surgical operation. Ideal sedative agent should follow for rapid modification of sedation level by modification of dosage (titrable) and should not have depressant effect on cardiovascular and respiratory system.

Midazolam remains the most popular because of its predictable sedative, anxiolytic and amnestic properties irrespective of the route of administration (i.e. oral, topical or parenteral). [5,6,7,8] Propofol, IV sedative hypnotic of choice at the present time has been found to be equivalent to midazolam for providing adequate sedation and amnesia during regional anaesthesia. [9,10,11,12] Dexmedetomidine is a new highly selective and potent alpha-2 adrenoceptor agonist offering sedation and anxiolysis, has analgesic qualities and reduce the stress response to surgery and intensive care procedure.

Aim and Objectives

To compare dexmedetomidine, propofol and midazolam in intraoperative and postoperative sedation in regional anaesthesia.

To provide better haemodynamic control and better sedation and analgesia in intra- and post-operative period with minimal complications.

To provide safety, comfort and amnesia for both the block and surgical procedure.

MATERIALS AND METHODS

This randomised, double-blind, controlled trial was conducted on 80 patients in the Department of Anaesthesiology, Sardar Patel Medical College and Associated Group of Hospitals, Bikaner, after taking permission from Institution Research Board. Both male and female patients ranging between the age group of 20-60 years belonging to ASA grades I and II, weighing 40-70 kg, scheduled for elective lower limb or lower abdominal surgical procedure which all anticipated to complete within 2 hours under regional anaesthesia were included in selection of patients.

80 adult patients of either sex were included, belonging to ASA grades I and II. They were randomised into 4 groups and efforts were made that the group do not significantly differ with respect to age, weight and height. Sample size was calculated considering two-sided alpha error at 5% and power of study 80% with formula m = 2c/delta + 1 (where c= 7.9 for power 80% and delta in standardised effect size derived from prior studies as .9) and was 19.55 (rounded to 20) for each group.

Exclusion Criteria

Patient with history of allergic reaction to the study drugs; those with significant cardiac, pulmonary, hepatic or renal dysfunction; obese patients (> 130% ideal body weight); those with history of chronic use of sedative drugs; full stomach patients, pregnant patients and epileptic patients all were excluded from the study. Pre-anaesthetic checkup.

Pre-anaesthetic checkup was carried out the day before surgery. Routine lab investigations like haemogram, blood sugar, blood urea, serum creatinine, chest x-ray and ECG were done. Standard monitors were applied with noninvasive BP, PR, Heart rate and SPO2 were recorded. The patients were divided into 4 groups of 20 patients in each group.

Group I

Patients received spinal anaesthesia and IV sedation with midazolam infusion 0.5 mg/kg/hr.

Group II

Patients received spinal anaesthesia and IV sedation with propofol 6 mg/kg/hr.

Group III

Patients received spinal anaesthesia and IV sedation with dexmedetomidine infusion 0.6 microgram/kg/hr.

Group IV

Patients received spinal anaesthesia and IV infusion of normal saline.

Procedure

Patients were taken on operating table and baseline BP, Pulse rate, Respiratory rate and SPO2 were recorded. The patients were subsequently shifted to the operating room and were randomly allocated with the help of computer generated random number to receive either propofol 1 mg/mL (in 5% dextrose in 50 mL syringe) or midazolam 0.1 mg/mL (5% dextrose in 50 mL syringe) or dexmedetomidine 2 microgram/mL (in normal saline in 50 mL syringe) through intravenous infusion. Midazolam was started at an initial infusion rate of 0.5 mg/kg/hr or dexmedetomidine started at an infusion rate 0.6 microgram/kg/hr to achieve desired level of sedation score 4 was noted. The infusion rate was lowered or raised in order to maintain sedation score of 4. After achieving a sedation score of 4, subarachnoid block was instituted by injecting 2.5 mL of bupivacaine heavy 0.5% to achieve adequate sensory block. Sedation score, systolic BP, diastolic BP, HR and SPO2 were recorded 5 mins before intrathecal injection and every 5 mins after intrathecal injection for 30 mins, then every 15 mins after up to 90 mins till the surgery continues, then every 2 hours until the patient is under sedation.

Prediction of depth of sedation and anaesthesia was noted by observer's assessment of alertness/sedation score.

Score 5

Responsiveness- Respond readily to voice with normal tone.

Speech-Normal.

Facial Expression-Normal.

Eyes-Clear, No ptosis.

Score 4

Responsiveness-Respond slowly to voice with normal tone.

Speech-Mild slowing.

Facial Expression-Mild relaxation.

Eyes-Marked ptosis (less than half the eye).

Score 3

Responsiveness-Respond after calling loudly or repeatedly.

Speech-Prominent slowing or slurring.

Facial Expression-Marked relaxation.

Eyes-Marked ptosis (half the eye or more).

Score 2

Responsiveness-Respond after mild prodding or shaking.

Speech-Few recognisable words.

Facial Expression-No response.

Eyes-No response.

Score 1

Responsiveness-Does not respond to mild prodding or shaking.

Speech-No Response.

Facial Expression-No response.

Eyes-No response.

Score 0

Responsiveness-Does not respond to pain.

Speech-No Response.

Facial Expression-No response.

Eyes-No response.

All patients were given supplementary oxygen via ventimask at 4 L/min.

Time to reach postoperative analgesic drug required was noted. Analgesia score was assessed by Visual analgesia score (VAS).

The study data analysed by using Analysis of Variance (ANOVA) and Chi-square test SPSS software 10.0.

Observations

Observation/ Statistical Analysis Tables from 1 to 9.

RESULTS

There were no significant differences between the four groups with regard to age, weight and gender of the patients. We observed Pulse rate, Systolic blood pressure, Diastolic blood pressure and SPO2 to various extent. There was gradual fall in the pulse rate upto 45 mins following spinal anaesthesia in each group. No significant change in pulse was seen when intergroup comparison was made between four groups till 90 mins. Comparison of mean systolic blood pressure at various intervals in 4 groups showed that the groups were statistically highly significant (p < 0.001) till 45 minutes. After 45 minutes the difference was statistically significant (p < 0.05). It was highly significant in group propofol till 45 minutes than other groups. The intergroup comparison of mean diastolic blood pressure showed that the groups were statistically significant (p < 0.05) till 15 mins and after 15 mins till 45 mins it was highly significant. No clinical significant changes in SPO2 was seen when intergroup comparison was made between 4 groups.

We also observed time taken for onset of sedation, which was earliest in propofol group and prolonged in dexmedetomidine group as compared to midazolam group. The statistical intergroup comparison shows the highly significant difference in all the groups (p < 0.001).

Hypotension was seen in 2 patients in group propofol. Bradycardia was seen in 1 patient in each midazolam and propofol group, while nausea and vomiting was present in 1 case in each group of midazolam, dexmedetomidine and control group, while urinary retention was seen in 2 cases in all the 4 groups. This difference was statistically insignificant (p > 0.05).

Maximum mean postoperative analgesia was in group dexmedetomidine followed by group midazolam, propofol and control respectively. Intergroup comparison was highly significant in all groups (p < 0.001).

Time taken to reach sedation score 5 was lowest in group II propofol (10.75 +/- 3.37 minutes) and maximum in group III dexmedetomidine (156.00 +/- 47.28 minutes). Time taken in group I midazolam (27.25 +/- 20.36 minutes).

DISCUSSION

The use of spinal anaesthesia is often limited by the unwillingness of the patient to remain awake during surgery. Supplemental sedation with an intravenous agent is often required to allay fear and anxiety in patients subjected to spinal anaesthesia. Most widely used technique for administering sedation in regional anaesthesia is the intermittent intravenous bolus dose technique. This technique is associated with peaks and troughs in plasma concentration producing significant side effects and delayed recovery. Continuous infusions have been proved to produce lesser side effects, faster recovery and easy controllability over the desired level of sedation.

Mean pulse rate reduced in all the 4 groups upto 90 minutes. Magalhaes et al [13] found that were no statistical significant difference between dexmedetomidine and midazolam groups in heart rate variation. Celik et al [14] also found that in comparison to propofol, dexmedetomidine achieved more stable haemodynamic parameters. Similar results were observed in our study.

Mean systolic blood pressure reduced in all 4 groups upto 90 minutes. Intergroup comparison significant (p < 0.001). The mean diastolic blood pressure also reduced in all 4 groups upto 75 minutes following spinal anaesthesia, which was statistically highly significant (p < 0.001). The study correlates well with Arain and Ebert, [15] Magalhaes et al [13] and Celik et al [14] and Liang et al. [16]

Changes in SPO2 were clinically insignificant among all groups (p > 0.05). Our study correlates with Patki and Shelgaonkar. [17]

The mean time for onset of sedation as assessed by OASS score was found to be 9.00 +/- 1.72 mins, 7.15 +/- 1.66 mins and 18.25 +/- 2.12 mins in group I, II and III. Studies by Arain and Ebert, [15] Patki and Shelgaonkar [17] and Liang et al [16] correlates well with our study.

No significant complications were seen among groups. Our study favours studies by White and Smith [18] and Patki and Shelgaonkar. [17]

Maximum mean postoperative analgesia was highest in group III (Dexmedetomidine) followed by group I (midazolam) and group II (propofol) and group IV (control). Celik et al [14] found that time for first analgesic requirement was significantly longer in group dexmedetomidine as compared to midazolam. Kaya et al [19] concluded that dexmedetomidine increased the time for first request for postoperative analgesia compared with midazolam and saline. Our study correlates with above authors.

Time taken to reach complete awakening (Sedation Score 5) was highest in dexmedetomidine II group followed by midazolam I group and propofol II group. Intergroup comparison was significant. Our study corresponds with Yao et al. [20]

CONCLUSION

Operative condition was good and comparable with good haemodynamic stability in all 4 groups. Midazolam is highly suitable with significantly less pain on injection, lower incidence of postoperative venoirritation and its lower cost. Propofol is highly suitable as a sedative for spinal anaesthesia in spite of injection pain. It is superior to midazolam and dexmedetomidine, because of significantly early onset of sedation and shorter recovery time. Dexmedetomidine achieved similar level of sedation to midazolam and propofol in lower limb surgery under spinal anaesthesia. Patients sedated with dexmedetomidine could be easily aroused to cooperate with procedure without showing irritation. Adverse side effects of dexmedetomidine, midazolam and propofol are avoided by the slow infusion of drugs.

From the results of our clinical study we concluded that all the three drugs provide good sedation, stable haemodynamics, no respiratory depression and alertness with good cooperation. Midazolam is the drug of choice due to its cost benefit; propofol is preferred during ambulatory surgery under regional anaesthesia and dexmedetomidine is used as first option by the additional analgesic property.

REFERENCES

[1] Lonsdale M, Hutchison GL. Patient's desire for information about anaesthesia. Scottish and Canadian attitudes. Anaesthesia 1991; 46(5):410-2.

[2] Asehnoune K, Albaladejo P, Smail N, et al. Information and anaesthesia: what does the patient desire? ANN Fr Anesth Reanim 2000; 19(8):577-81.

[3] Gajraj NM, Sharma SK, Souter AJ, et al. A survey of obstetric patients who refuse regional anaesthesia. Anaesthesia 1995; 50(8):740-1.

[4] Marcario A, Weinger M, Carney S, et al. Which clinical anaesthesia outcomes are important to avoid? The persrective of patients. Anesth Analg 1999; 89(3):65-28.

[5] Vlymen VJJ, Sa Rego MM, White PF. Benzodiazepine premedication: can it improve outcome in patients undergoing breast biopsy procedures? Anaesthesiology 1999; 90(3):740-7.

[6] Al-Rakaf H, Bello LL, Turkostani A, et al. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent 2001; 11(1):33-40.

[7] Cote CJ, Cohen IT, Suresh S, et al. A comparison of three doses of a commercially prepared oral Original Research Article midazolam syrup in children. Anesth Analg 2002; 94(1):37-43.

[8] Habib NE, Mandour NM, Balmer HG. Effect of midazolam on anxiety level and pain perception in cataract surgery with topical anaesthesia. J Cataract Refract Surg 2004; 30(2):437-43.

[9] White PF, Negus JB. Sedative infusions during local and regional anesthesia: a comparison of midazolam and propofol. J Clin Anesth 1991; 3(1):32-9.

[10] Ferrari LR, Donlon JV. A comparison of propofol, midazolam and methohexital for sedation during retrobulbar and peribulbar block. J Clin Anesth 1992; 4(2):93-6.

[11] Pratila MG, Fischer ME, Alagesan R, et al. Propofol vs midazolam for monitored sedation: a comparison of intraoperative and recovery parameters. J Clin Anesth 1993; 5(4):268-74.

[12] Cillo JE. Propofol anaesthesia for outpatient for oral and maxillofacial surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999; 87(5):530-8.

[13] Magalhaes E, Ladeira LC, Govera CS, et al. Intravenous dexmedetomidine for sedation does not interfere with sensory and motor block duration during spinal anaesthesia. Rev Bras Anestesiol 2006; 56(1):1-7.

[14] Celik M, Koltka N, Cevik B, et al. Intraoperative sedation during epidural anesthesia: dexmedetomidine vs midazolam. The Internet J Anesthesiology 2008; 17(2):27.

[15] Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg 2002; 95(2):461-6.

[16] Liang Y, Gu M, Wang S, et al. A comparison of dexmedetomidine and midazolam for sedation in gynaecologic surgery under epidural anaesthesia. J Curr Surg 2011; 1(1):12-8.

[17] Patki A, Shelgaonkar VC. A comparison of equisedative infusions of propofol and midazolam for conscious sedation during spinal anaesthesia-a prospective randomised study. J Anaesthesiol Clin Pharmacol 2011; 27 (1):47-53.

[18] White PE, Smith I. Use of sedation techniques during local and regional anaesthesia. Can J Anaesth 1995; 42(1):38-54.

[19] Kaya FN, Yavascaoglu B, Turker G, et al. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth 2010; 57(1):39-45.

[20] Yao L, Zhou XM, Zhao JJ. The role of dexmedetomidine in treatment of serious patients in intensive care unit. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue 2010; 22(10):632-4.

Kiwi Mantan (1), Anita Pareek (2), RashmiJain (3), Anju Meena (4), Pramiia Soni (5), AditiSharma (6)

(1) Assistant Professor, Department of Anaesthesia, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan.

(2) Professor, Department of Anaesthesia, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan.

(3) Senior Registrar, Department of Anaesthesia, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan.

(4) Senior Registrar, Department of Anaesthesia, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan.

(5) Assistant Professor, Department of Anaesthesia, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan.

(6) Intership Trainee, Lady Hardinge, MC New Delhi.

Financial or Other, Competing Interest: None.

Submission 24-07-2017, Peer Review 06-09-2017, Acceptance 12-09-2017, Published 18-09-2017.

Corresponding Author:

Dr. Anita Pareek, 4/E/188, J. N. Vyas Colony, Bikaner, Rajasthan.

E-mail: dranitapareek23@gmail.com

DOI: 10.14260/jemds/2017/1168
Table 1. Showing Mean Pulse Rate at different Time Intervals in all
the 4 Groups

Mean Pulse       Group I       Group II        Group III

             Mean     SD     Mean     SD     Mean     SD

0 Minute     87.80   10.58   82.30   6.22    88.75   13.09
5 Minutes    84.00   10.91   83.00   7.10    85.10   12.18
10 Minutes   81.15   11.70   79.15   8.32    83.15   12.35
15 Minutes   78.70   13.52   76.63   8.29    81.50   12.34
20 Minutes   79.45   12.91   74.58   8.73    79.05   12.55
25 Minutes   79.50   12.41   73.79   10.14   77.25   11.47
30 Minutes   77.10   9.01    72.11   8.01    75.90   9.56
45 Minutes   77.88   8.08    72.00   7.73    76.44   7.82
60 Minutes   75.00   3.00    71.33   6.25    74.86   8.40
75 Minutes   72.75   2.50    69.67   4.66    73.00   5.00
90 Minutes   72.00   2.45    62.25   2.21    72.00   0.00
2 Hours      80.10   7.33    76.80   6.30    80.40   6.60
4 Hours      81.00   7.83    78.40   7.33    82.50   6.65
6 Hours      82.30   5.40    81.30   7.79    84.70   5.96
8 Hours      81.60   6.89    82.30   8.57    81.90   6.88
12 Hours     82.30   6.50    81.80   8.48    80.70   7.06
24 Hours     82.30   4.96    80.20   7.11    81.80   7.05

Mean Pulse     Group IV      CD5%      P
             Mean     SD

0 Minute     90.70   16.58   1.738   0.166
5 Minutes    86.30   14.26   0.310   0.818
10 Minutes   85.25   14.40   0.971   0.411
15 Minutes   81.65   14.17   0.743   0.530
20 Minutes   82.80   15.15   1.396   0.251
25 Minutes   80.70   15.25   1.149   0.335
30 Minutes   79.05   15.58   1.000   0.398
45 Minutes   78.32   13.59   0.635   0.595
60 Minutes   75.17   9.89    3.779   0.021
75 Minutes   73.00   7.00    4.937   0.014
90 Minutes   73.50   0.071   1.446   0.309
2 Hours      78.60   12.33   0.753   0.524
4 Hours      81.10   12.03   0.770   0.514
6 Hours      82.30   11.88   0.627   0.600
8 Hours      81.90   10.33   0.024   0.995
12 Hours     81.30   9.18    0.151   0.929
24 Hours     83.20   9.25    0.776   0.511

Table 2. Showing Mean Systolic Blood Pressure (mmHg) at different
Time Intervals in all the 4 Groups

Systolic BP     Group I        Group II           Group III
(mmHg)         Mean     SD      Mean     SD      Mean     SD

0 Minute      124.65   12.58   122.5    12.22   130.85   12.89
5 Minutes     113.95   12.55   117.75   11.63   121.25   15.49
10 Minutes    110.00   12.54   111.1    13.91   116.05   17.14
15 Minutes    109.20   15.37    107     12.65   113.50   15.81
20 Minutes    107.25   15.88   103.58   9.23    115.05   15.10
25 Minutes    106.70   13.27   103.32   11.56   114.70   13.78
30 Minutes    108.53   12.92   104.78   11.45   114.35   13.32
45 Minutes    107.00   13.23   102.27    7.2    116.53   9.96
60 Minutes    99.40    15.13   99.44    6.09    114.00   11.27
75 Minutes    94.75    7.09    100.33    6.5    103.33   7.57
90 Minutes    95.25    4.57     103     4.97    98.00    0.00
2 Hours       112.00   8.94    115.4    7.54    115.00   7.61
4 Hours       118.50   10.89   119.3    5.78    122.70   10.04
6 Hours       123.70   8.27     122     7.57    123.00   8.91
8 Hours       122.70   10.75   121.3    9.18    125.90   8.47
12 Hour       125.20   10.31   120.2    7.22    123.90   9.35
24 Hours      124.50   9.45    119.4    6.87    120.60   7.02

Systolic BP        Group IV    CD5%      P
(mmHg)         Mean     SD

0 Minute      137.85   10.95   6.420   0.001
5 Minutes     129.00   13.78   4.548   0.006
10 Minutes    128.15   15.15   6.321   0.001
15 Minutes    127.65   16.52   7.379   <0.001
20 Minutes    125.80   15.78   9.299   <0.001
25 Minutes    125.25   17.15   9.401   <0.001
30 Minutes    124.16   15.94   7.282   <0.001
45 Minutes    121.80   18.17   7.468   <0.001
60 Minutes    119.40   19.31   4.288   0.013
75 Minutes    119.00   15.59   5.054   0.013
90 Minutes    122.50   17.68   5.323   0.032
2 Hours       118.80   7.74    2.433   0.071
4 Hours       125.60   12.37   2.108   0.106
6 Hours       128.90   9.98    2.492   0.066
8 Hours       125.30   6.99    1.175   0.325
12 Hour       125.90   7.47    1.710   0.172
24 Hours      125.00   9.74    2.224   0.092

Table 3. Showing Mean Diastolic Blood Pressure (mmHg) at different
Time Intervals in all the 4 Groups

Diastolic BP       Group I         Group II        Group III
(mmHg)         Mean     SD     Mean     SD     Mean     SD

0 Minute       82.80   8.69    80.70   6.84    84.40   10.03
5 Minutes      76.35   9.19    77.40   7.92    79.50   8.49
10 Minutes     73.20   9.27    73.35   8.68    76.25   8.72
15 Minutes     71.60   10.65   68.89   9.10    74.35   8.74
20 Minutes     70.00   9.02    66.63   7.80    75.90   9.14
25 Minutes     70.30   7.08    66.42   9.47    74.30   7.95
30 Minutes     70.05   7.34    67.00   10.57   74.95   9.11
45 Minutes     70.29   8.76    64.20   8.01    76.12   8.07
60 Minutes     63.60   11.08   63.11   10.01   76.29   9.34
75 Minutes     65.25   11.76   63.78   9.91    67.67   8.74
90 Minutes     64.75   6.70    61.00   7.79    68.00   0.00
2 Hours        76.00   5.98    77.20   5.89    77.80   6.15

4 Hours        77.40   7.95    77.00   4.66    80.40   6.34
6 Hours        79.50   7.31    81.40   5.59    81.90   7.41
8 Hours        81.40   5.15    79.90   6.60    81.30   7.85
12 Hours       82.60   6.36    80.70   4.78    80.50   5.91
24 Hours       82.60   5.66    80.30   3.85    82.70   9.32

Diastolic BP       Group IV    CD5%      P
(mmHg)         Mean     SD

0 Minute       84.55   8.00    0.896   0.447
5 Minutes      83.85   7.42    3.214   0.028
10 Minutes     80.50   6.75    3.304   0.025
15 Minutes     79.40   8.71    4.527   0.006
20 Minutes     78.70   9.91    7.251   <0.001
25 Minutes     78.65   10.34   6.989   <0.001
30 Minutes     79.70   10.33   6.716   <0.001
45 Minutes     78.69   10.54   8.208   <0.01
60 Minutes     78.67   10.34   5.561   0.004
75 Minutes     78.67   14.15   1.469   0.263
90 Minutes     82.00   15.56   2.568   0.137
2 Hours        79.60   6.54    1.191   0.319

4 Hours        81.50   6.80    2.294   0.085
6 Hours        82.80   6.82    0.834   0.479
8 Hours        84.60   6.09    1.873   0.141
12 Hours       83.30   5.78    1.173   0.326
24 Hours       84.00   5.66    1.142   0.338

Table 4. Showing Mean Respiratory Rate (min) at different Time
Intervals in ail the 4 Groups

Respiratory       Group I        Group II       Group III
Rate (min)    Mean     SD    Mean     SD    Mean     SD

5 Minutes     15.65   0.75   15.65   0.67   15.95   60.60
10 Minutes    15.05   0.69   15.00   0.86   15.40   0.94
15 Minutes    14.80   1.01   14.84   0.96   14.95   0.76
20 Minutes    14.85   0.99   14.74   0.99   15.10   0.79
25 Minutes    15.00   0.79   14.58   0.90   14.90   0.79
30 Minutes    14.68   0.95   14.72   0.75   14.75   0.72
45 Minutes    14.56   0.63   14.47   1.06   14.88   0.86
60 Minutes    14.20   0.45   14.33   1.12   14.43   0.53
75 Minutes    13.50   1.00   14.33   0.71   14.33   0.58
90 Minutes    13.50   1.00   14.25   0.50   14.00   0.00
2 Hours       15.90   0.31   15.85   0.50   15.75   0.44
4 Hours       15.70   0.73   15.90   1.29   15.75   0.64
6 Hours       15.95   1.50   16.70   1.45   16.80   1.82
8 Hours       16.05   1.15   17.05   2.50   17.10   2.07
12 Hours      16.15   0.93   16.85   1.14   17.25   2.81
24 Hours      16.30   1.08   17.00   1.26   16.25   1.45

Respiratory       Group IV   CD5%      p
Rate (min)    Mean     SD

5 Minutes     15.70   1.56   0.434   0.729
10 Minutes    15.95   1.82   2.337   0.054
15 Minutes    15.55   1.43   2.120   0.105
20 Minutes    15.55   1.27   2.437   0.071
25 Minutes    15.35   1.27   2.140   0.102
30 Minutes    15.35   1.31   2.122   0.105
45 Minutes    15.26   1.19   2.391   0.077
60 Minutes    15.83   1.95   2.444   0.061
75 Minutes    13.67   1.52   1.060   0.395
90 Minutes    14.50   0.71   0.961   0.462
2 Hours       16.10   1.21   0.869   0.461
4 Hours       16.05   1.19   0.495   0.687
6 Hours       17.20   1.54   2.161   0.100
8 Hours       17.55   1.70   2.170   0.098
12 Hours      17.60   1.73   2.377   0.076
24 Hours      16.95   1.43   1.906   0.136

Table 5. Showing Mean SPO2 at different Time Intervals in all the 4
Groups

SP[O.sup.2] (%)       Group I        Group II     Group III
                  Mean     SD    Mean     SD    Mean     SD

5 Minutes         99.10   1.07   99.20   1.06   99.05   0.94
10 Minutes        98.85   1.04   98.95   1.36   98.65   0.99
15 Minutes        98.85   1.04   99.42   0.96   99.15   0.93
20 Minutes        99.15   0.93   99.26   1.59   99.45   0.99
25 Minutes        99.50   0.69   99.16   1.07   99.55   0.60
30 Minutes        99.47   0.77   99.17   0.99   99.60   0.60
45 Minutes        99.35   0.93   99.13   0.92   99.65   0.79
60 Minutes        99.00   1.22   98.78   1.20   99.00   1.15
75 Minutes        99.00   1.15   98.50   1.31   98.67   0.58
90 Minutes        99.25   0.96   99.25   0.96   99.00   0.00
2 Hours           97.20   0.70   97.70   1.22   97.80   1.28
4 Hours           97.15   0.37   97.65   1.09   97.35   0.81
6 Hours           97.20   0.41   97.65   1.09   97.40   0.88
8 Hours           97.25   0.44   97.40   0.50   97.30   0.47
12 Hours          97.25   0.44   97.45   0.76   97.10   0.72
24 Hours          97.30   0.47   97.80   1.06   97.30   0.47

SP[O.sup.2] (%)        Group IV   CD5%      P
                   Mean     SD

5 Minutes         99.65    0.75   1.617   0.192
10 Minutes        99.55    0.83   2.621   0.057
15 Minutes        99.60    0.75   2.481   0.067
20 Minutes        99.80    0.70   1.336   0.269
25 Minutes        99.65    0.75   1.406   0.248
30 Minutes        99.70    0.80   1.584   0.201
45 Minutes        99.68    0.67   1.633   0.190
60 Minutes        99.50    1.00   0.783   0.513
75 Minutes        100.00   0.00   1.431   0.276
90 Minutes        99.50    0.71   0.071   0.974
2 Hours           97.25    0.44   1.974   0.125
4 Hours           97.45    0.51   1.546   0.209
6 Hours           97.45    0.51   1.141   0.338
8 Hours           97.60    0.60   1.863   0.143
12 Hours          97.40    0.50   1.297   0.282
24 Hours          97.45    0.60   2.313   0.083

Table 6. Showing Distribution of Cases according to Onset of Sedation
in all the 4 Study Groups

Onset of        Group I      Group II    Group III     Group IV
Sedation    No.     %     No.     %     No.     %     No.   %
(Minutes)

5-7          2      10     11    55      0      --    --    --
8-10         15     75     8     40      0      --    --    --
11-14        3     15.0    1      5      2     10.0   --    --
15-20        0      --     0     --     16      80    --    --
>20          0      --     0     --      2     10.0   --    --
Total        20    100     20    100    20     100    --    --
Mean        9.00          7.15         18.25          --    --
SD          1.72          1.66         2.12           --    --

                                         t             p

Group I vs II                          3.461          =0.001
Group I vs III                         15.145         <0.001
Group II vs III                        18.399         <0.001

Table 7. Showing Distribution of Cases according to Complications in
all Four Groups

Complications           Group I      Group II   Group III   Group IV
                     No.      %    No.    %    No.    %    No.    %

Nil                   15     75    16    80    15    75    16    80
Hypotension           0      --     2    10     0    --     0    --
Bradycardia           1       5     0    --     1     5     0    --
Nausea                1       5     0    --     1     5     1     5
Vomiting              1       5     0    --     1     5     1     5
Urinary Retention     2      10     2    10     2    10     2    10
Total                 20     100   20    100   20    100   20    100
X2                  14.486
P                   0.106

Complications          Total
                    No.    %

Nil                 62    77.5
Hypotension          2    2.5
Bradycardia          2    2.5
Nausea               3    3.7
Vomiting             3    3.7
Urinary Retention    8     10
Total               80    100
X2
P

Table 8. Showing Distribution of Cases according to Postoperative
Analgesia in ail the 4 Groups

Postoperative      Group I     Group II      Group III     Group IV
Analgesia       No.     %    No.     %     No.      %     No.      %
(Hours)

0-2              5     25     15    75      0      --      20     100
3-4              15    75     5     25      3      15      0      --
5-6              0     --     0     --      7      35      0      --
>6               0     --     0     --      10     50      0      --
Total            20    100    20    100     20     100     20     100
Mean            3.15         1.93          6.55           1.25
SD              0.86         0.96          1.76           0.62
                                            t              p
Group I vs II                             4.242          <0.001
Group I vs III                            7.757          <0.001
Group I vs IV                             8.025          <0.001
Group II vs III                           10.302         <0.001
Group II vs IV                            2.638          0.012
Group III vs IV                           12.698         <0.001

Table 9. Showing Distribution of Cases according to Time Taken to
reach Sedation Score 5

Time                 Group I       Group II      Group III
Taken              No.     %     No.     %     No.      %
(Minutes)

0-60               17     85     20     100     0      --
61-120              3     15      0     --      14     70
121-180             0     --      0     --      4      20
181-240             0     --      0     --      1       5
>240                0     --      0     --      1       5
Total              20     100    20     100     20     100
Mean              27.25         10.75         156.00
SD                20.36         3.37          47.28
                                                T
Group I vs II                                 3.576
Group I vs III                                11.185
Group II vs III                               13.703

Time                 Group IV      Total
Taken              No.     %    No.    %
(Minutes)

0-60                0      --   37    61.7
61-120              0      --   17    28.3
121-180             0      --    4    6.7
181-240             0      --    1    1.7
>240                0            1    1.7
Total               0      --   60    100
Mean                --
SD                  --
                    p
Group I vs II     =0.001
Group I vs III    <0.001
Group II vs III   <0.001
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Title Annotation:Original Research Article
Author:Mantan, Kiwi; Pareek, Anita; Jain, Rashmi; Meena, Anju; Soni, Pramila; Sharma, Aditi
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Report
Geographic Code:9INDI
Date:Sep 18, 2017
Words:5365
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