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COMPARISON OF THE EFFECT OF INTRA-CUFF KETAMINE VEERSUS ALKALINIZED LIDOCAINE FOR PREVENTION OF POST-OPERATIVE SORE THROAT.

Byline: Nadeem Naqvi, Arif Iftikhar Mallhi, Ali Asgher and Umer Rafique

Keywords: Alkalinized lidocaine, Ketamine, Post-operative sore throat.

INTRODUCTION

Post-operative sore throat (POST) occurs in 2165% of patients receiving general anesthesia (GA) with tracheal intubation 1,2. Though considered as a minor complication, but it may cause significant post-operative morbidity and patient dissatisfaction 3. Various non-pharmacological and pharmacological trials have been used for attenuating POST with no proven single modality. The pharmacological methods used to reduce POST include use of beclomethasone gel, gargling with azulenesulphonate, ketamine and licorice, intra-cuff ketamine and alkalinized lidocane 4-6. Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects 6,7.

Previous studies with in vitro and in vivo approaches that used large doses (200-500 mg) of lidocaine hydrochloride (L-HCl) instead of saline have shown that L-HCl could slowly diffuse through the cuff, and this could be dangerous if the cuff ruptured 8,9. The purpose of our study was to evaluate the effectiveness of endotracheal intracuff lidocaine vs alkalinized lidocaine in reducing the POST. POST happens in 21-65%of patients accepting GA with tracheal intubation 1,2.

However considered as a minor complexity, yet it might cause huge post-ope-rative dismalness and persistent dissatisfaction 3. Diffe-rent non-pharmacological and pharmacological preli-minaries have been utilized for weakening POST with no demonstrated single methodology.

The pharmacological strategies used to diminish POST incorporate utilization of beclomethasone gel, swishing with azulenesulphonate, ketamine and licorice, intra-cuff ketamine and alkalinized lidocaine 4-6. Ketamine is a NMDA receptor foe and has been utilized as a wash for lessening the occurrence and seriousness of POST because it's enemy of nociceptive and calming effects 6,7.

Past investigations with in vitro and in vivo approaches that utilized substantial dosages (200-500 mg) of lidocaine hydrochloride (L-HCl) rather than saline have demonstrated that L-HCl could gradually diffuse through the sleeve, and this could be perilous if the cuff ruptured 8,9. The motivation behind our examination was to assess the viability of endotracheal intracuff lidocaine versus alkalinized lidocaine in diminishing the POST.

METHODOLOGY

This prospective comparative study was conducted by the department of anesthesiology, Liaquat National Hospital and Medical College, Karachi, after the approval of the study from the Institutional Ethical Board, from April to July 2018. Non-probability (consecutive sampling technique was used using formula N=Z) 2 p(1-P)/d2 with confidence level = 95% and Power of d=80% with incidence of POST (with intracuff) ketamine versus alkalinized lidocaine = 34% vs 56%. The study was conducted. Once an eligible patient has been identified in the preoperative round meeting the inclusion and exclusion criteria, the study details were carefully discussed with the potential subject and informed consent attained. Randomization was done using a lottery method for the selected patient. If the patient was illiterate, then the informed consent form was read to the patient and if consent was given, it was signed and dated by an impartial witness who was independent of the Principal Investigator.

A performa was filled by the investigator as a data collecting tool for preoperative and postoperative assessment. A total of total 70 patients were selected using a non-probability consecutive sampling technique. Group were allocated randomly as group K and group LA using a lottery method. Once the patient was identified then General Anesthesia was given using induction dose of propofol 2-3 mg/kg. nalbuphine 0.1 mg/kg and atracurium 0.5 mg/kg and patients were intubated with 7.0 mm size ETT for females and 8.0 mm size ETT for male patients. All intubations were performed by an anesthesiologist with minimum of two year experience. ETT cuff was inflated by using Ketamine 2.5% in Normal Saline in group K and 2% lidocaine with 8.4% Sodium bicarbonate in LA group till the air leak was diminished. After surgery patient was assessed on extubation for any emergence phenomena and then were assessed for 1 st 6 th 12 th and 24 th hour post surgery for outcome. The assessment was done by the on call anesthesiology resident who was blinded of the study group. Any patient who developles post-operative sore throat was given dexamethasone 8 mg IV stat and advised warm normal saline gargles.

Principal investigator recorded all clinical history demography on a perfoma that was already designed, Informed on paper consent was taken before enrollment. Exclusion criteria was firmly followed to avoid confounding variables.

For analyzing the data SPSS-22 was used. Mean and standard deviation was computed for calculation of quantitative variables like age and for qualitative variables i.e. gender and paraprotienemia. Frequencyand percentage was calculated. Chi-square test was applied for post satisfication; p-value a$?0.05 was taken as significant.

RESULTS

A total of 70 participants who were undergoing General anesthesia with endotracheal intubation as per inclusion criteria were included in our study. Patients were randomly divided into two groups, group K patients were given intra-cuff ketamine and group LA patients were given alkalinized lidocaine and assessed by severity of post operative sore throat, cough, Hoarseness, laryngeal spasm, heart rate and blood pressure.

Group 'K' included 35 subjects of which 20 (57%) were male while 15 (43%) were female, with mean age of 36.51 +- 14.13 years, group 'LA' also included 35 patients of which 21 (60%) were male while 14 (40%) were female, with mean age 36.29 +- 14.6 years as shown in table-I. The overall mean age came out to be 36.40 +- 14.26 years as shown in table-I.

Table-I: Age and gender distribution in two study groups.

Age 2 +-###Kalimine###Alkalinized###p-

Groups###Group###Lidocaine Group###value

Mean +- SD###36.51 +-###36.29 +- 14.6###0.624

(years)###14.13

Gender

Male###20 (57%)###21 (60%)###0.806

Female###15 (43%)###14 (40%)

In our study the co-morbids in group K were diabetes mellitus (DM) in 2 (6%), hypertension in 4 (11%), Breast carcinoma in 1 (3%), hepatitis C in 1 (3%), Hypertension/Asthma in 1 (3%), Hypertension/Parkinson's disease in 1 (3%), No known co-morbids in 25 (71%), while in group LA Diabetes mellitus (DM) in 1 (3%), hypertension in 2 (6%), Breast carcinoma in 0 (0%), Hepatitis C in 0 (0%), Hypertension/Asthma in 1 (3%), DM/Hypertension 2 (6%), No known co-morbids in 27 (77%), as shown in table-II.

Severity of sore throat pain in group K at 15 minutes was mild in 10 (28.5%) and no pain in 25 (71.5%), at 1 hour was mild in 8 (22.8%) and no pain in 27 (77.1%), at 3 hours was mild in 2 (5.7%) and no pain in 33 (94.3%) and 24 hours was mild in 0 (%) and no pain in 35 (100%), while in group LA severity of sore throat pain at 15 minutes was mild in 10 (28.5%) and no pain in 25 (71.5%), at 1 hour was mild in 2 (5.7%) and no pain in 33 (94.3%), at 3 hours was mild in 2 (5.7%) and no pain in 33 (94.3%) and 24 hours was mild in 0 (0%) and no pain in 35 (100%) as shown in table-III.

Cough in group Kat 15 minutes post operatively was noted in 4 (11.5%), at 1 hour in 3 (8.5%), at 3 hours in 0 (0%) and at 24 hours in 1 (2.8%), while in group LA at 15 minutes post operatively was noted in 9 (25.7%), at 1 hour in 5 (14.2%), at 3 hours in 0 (0%) and at 24hours was noted in none patient 0 (0%), as shown in table-III.

Table-II: Co-morbids distribution in two study groups.

Co-Morbids###Kalimine Group###Alkalinized Lidocaine Group###p-value

Diabetes mellitus (DM)###2 (5.7%)###1 (2.8%)

Hypertension###4 (11.4%)###2 (5.7%)

Breast carcinoma###1 (2.8%)###1 (2.8%)

Hepatitis C###1 (2.8%)###1 (2.8%)###0.806

Hypertension/Asthma###1 (2.8%)###1 (2.8%)

Hypertension/Parkinson's disease###1 (2.8%)###-

Diabetes Mellitus/ Hypertension###-###2 (5.7%)

No known co-morbids###25 (71.4%)###27 (77.1%)

Table-III: Severity of pain at 15 minutes, 1 hour, 3 hours and 24 hours, Cough at 15 minutes, 1 hour, 3 hours and 24 hours distribution with is study groups.

Severity of Sore###Kalimine Group###Alkalinized Lidocaine Group###p-value

Throat Pain###Mild pain###No Pain###Mild pain###No Pain

15 minutes###10 (28.5%)###25 (71.5%)###10 (28.5%)###25 (71.5%)###1.000

1 hour###8 (22.8%)###27 (77.2%)###2 (5.7%)###33 (94.3%)###0.04

3 hours###2 (5.7%)###33 (94.3%)###2 (5.7%)###33 (94.3%)###1.000

24 hours###-###35 (50%)###-###35 (50%)###1.000

###Kalimine Group###Alkalinized Lidocaine Group

Cough###Yes###No###Yes###No

15 minutes###4 (11.5%)###31 (88.5%)###9 (25.7%)###26 (74.3%)###0.12

1 hour###3 (8.57%)###32 (91.43%)###5 (14.3%)###30 (85.7%)###0.70

3 hours###-###35 (50%)###-###35 (50%)###1.000

24 hours###1 (2.8%)###34 (97.2%)###-###35 (50%)###0.999

###Kalimine Group###Alkalinized Lidocaine Group

Hoarseness###Yes###No###Yes###No

15 minutes###1 (2.8%)###34 (97.3%)###1 (2.8%)###34 (97.2%)###1.000

1 hour###1 (2.8%)###34 (97.2%)###1 (2.8%)###34 (97.2%)###1.000

3 hours###-###35 (50%)###-###35 (50%)###1.000

24 hours###-###35 (50%)###-###35 (50%)###1.000

###Kalimine Group###Alkalinized Lidocaine Group

Laryngeal Spasm###Yes###No###Yes###No

15 minutes###1 (2.8%)###34 (97.2%)###3 (8.5%)###32 (91.5%)###0.62

1 hour###-###35 (50%)###-###35 (50%)###1.000

3 hours###-###35 (50%)###-###35 (50%)###1.000

24 hours###-###35 (50%)###-###35 (50%)###1.000

Table-IV: Pre-operative heart rate, heart rate at 15 minutes, 1 hour, 3 hours and 24 hours.

Heart Rate###Kalimine Group###Alkalinized Lidocaine Group###p-value

###57-85###86-135###57-85###86-135

Pre-operative heart rate###16 (45.7%)###19 (54.3%)###13 (37.2%)###22 (62.8%)###0.47

Mean heart rate###88.20 +- 18.52###86.97 +- 11.12

Post operative at 15 minutes###11 (31.4%)###24 (68.6%)###5 (14.3%)###30 (85.7%)###0.090

Mean and standard deviation###89.86 +- 12.79###96.83 +- 11.28

At 1 hours###16 (45.7%)###19 (54.3%)###7 (20%)###28 (80%)###0.020

Mean and standard deviation###86.63 +- 13.25###91.34 +- 8.26

At 3 hours###20 (57.1%)###15 (42.9%)###15 (42.9%)###20 (57.1%)###0.230

Mean and standard deviation###84.60 +- 13.27###88.74 +- 8.90

At 24 hours###25 (71.4%)###10 (28.6%)###14 (40%)###21 (60%)###0.010

Mean and standard deviation###81.74 +- 12.14###87.44 +- 8.21

Hoarseness was only noted in group K at 15 minutes in 1 (2.8%), at 1 hour in 1 (2.8%), not noted at 3 hours and at 24 hours, while in group LA also noted at15 minutes in 1 (2.8%), at 1 hour in 1 (2.8%), not noted at 3 hours and at 24 hours, as shown in table-III.

Laryngeal spasm was only noted at 15 minutes in group K in 1 (2.8%), while in group LA in 3 (8.57%), it was not noted at 1 hour, at 3 hours and at 24 hours, as shown in table-III.

The mean heart rate in group K, per operatively was 88.20 +- 18.52 b/min, post operatively at 15 mins was 89.86 +- 12.79, at 1 hours 86.63 +- 13.25, at 3 hours 84.60 +- 13.27 and at 24 hours was 81.74 +- 12.14, while in group LA heart pre operatively was 86.97 +- 11.11, at 15 mins was 96.83 +- 11.28, at 1 hour 91.34 +- 8.26, at 3 hours 88.74 +- 8.90 and at 24 hours was 87.44 +- 8.21, as shown in table-IV. Blood pressure in both groups pre operatively, at 15 minutes, 1 hour, 3 hours and at 24 hours is given in table-V.

Table-V: Pre-operative blood pressure, blood pressure at 15 minutes, 1 hour, 3 hours and 24 hours distribution with in the study groups.

Blood Pressure###Kalimine Group###Alkalinized Lidocaine Group###p-value

###100/50-140/90###141/91-170/118###100/50-140/90###141/91-170/118

Pre-operative blood pressure###27 (77.1%)###8 (28.9%)###29 (82.9%)###6 (17.1%)###0.540

Post operative blood###30 (85.7%)###5 (14.3%)###23 (65.7%)###12 (34.3%)###0.050

pressure at 15 minutes

At 1 hours###29 (82.9%)###6 (17.1%)###29 (82.9%)###6 (17.1%)###1.000

At 3 hours###33 (94.3%)###2 (5.7%)###32 (91.4%)###3 (8.6%)###0.999

At 24 hours###32 (91.4%)###3 (8.6%)###32 (91.4%)###3 (8.6%)###1.000

DISCUSSION

Many of the general anesthetic procedures in the modern anesthetic practice are carried out with endotracheal intubation. Post-operative sore throat is a well recognized minor complication after general anesthesia 10. rated by patients as the 8 th most undesirable outcome in the post-operative period 11. Prophylactic management for decreasing its frequency and severity is still recommended to improve the quality of post anesthesia care though the symptoms resolve spontaneously without any treatment 12. POST is a parsimonious description representing a broad constellation of signs and symptoms of laryngitis, tracheaitis, hoarseness, cough or dysphagia 11. with incidence varying from 14.4-100% after endotracheal intubation 10. Research indicates that POST can be attenuated using a multi model approach consisting of pharmacological and non-pharmacological interventions. Identification of the factors associated with an increased risk of POST will allow anesthesia providers to avoid combination of controllable factors, decrease the incidence of POST and improve patients' anesthetic outcome. Many pharmacological interventions like steroids and non-ste-roidal anti-inflammatory drugs, lignocaine, have been used to attenuate POST by various authors. But all such maneuvers had their own limitations. Ketamine is in the middle of the affinity range of the uncompetitive NMDA antagonists which has been found by various authors to attenuate POST 12. An increasing amount of experimental data shows that NMDA receptors are found not only in central nervous system but also in the peripheral nerves. Peripherally administered NMDA receptor antagonists are involved with antinociception and anti-inflammatory cascade 13. by reducing NFK beta activity and TNF alpha production 14. expression of inducible nitric oxide synthase 15. serum C-reactive protein IL-6 and IL-10 16.

In the present examination, the rate of POST at 3 and 24 hours was diminished significantly, and theconstriction of seriousness of POST happened in the both groups however more generally in ketamine group at 15 minutes and 1 hour. The instrument of impact was potentially the topical impact of intra-cuff ketamine that lessened the nearby inflammation 17. Writing bolsters the topical impact of ketamine by means of its NMDA-hostile activity and mitigating impact dependent on creature demonstrate data 18. Ketamine is a NMDA receptor foe with the essential site of activity in the focal sensory system, and parts of the limbic framework while its utilization by means of nasal course, rinse, and rectal course proposes its fringe effect 19. Trial creature thinks about have demonstrated a defensive impact on airway inflammatory damage with ketamine 20.

The utilization of a little measurement of alkalized L-HCl uniquely enhanced ETT resistance amid a more delayed time frame. The utilization of alkalinized neighborhood soporifics in the ETT cuff offers the upsides of negligible pressure reaction to smooth extubation and hack free development. No cuff break was recorded in our examination which is like Estebe et al 21. think about and different previous studies 22-25. Thisoutcome affirmed that presentation of lidocaine isn't injurious for the cuff. Previous researches 22-25. have demonstrated that L-HCl set inside the cuff of an ETT can gradually diffuse through its hydrophobic structure.

Severity of sore throat pain in group K at 15 minutes was mild in 10 (28.5%) and no pain in 25 (71.5%), at 1 hour was mild in 8 (22.8%) and no pain in 27 (77.1%), at 3 hours was mild in 2 (5.7%) and no pain in 33 (94.3%) and 24 hours was mild in 0 (%) and no pain in 35 (100%), while in group LA severity of sore throat pain at 15 minutes was mild in 10 (28.5%) and no pain in 25 (71.5%), at 1 hour was mild in 2 (5.7%) and no pain in 33 (94.3%), at 3 hours was mild in 2 (5.7%) and no pain in 33 (94.3%) and 24 hours was mild in 0 (0%) and no pain in 35 (100%), as compare to one previous study in which overall postoperative sore throat was less in Ketamine group with 17 (34%) patients when compared to Alkalinized lidocaine group with 28 (56%) patients complaining of it with p=0.043.

STUDY LIMITATION

The main limitation was the small sample size. There were also different Anesthesiologists involved. Only 200 patients were enrolled in this study due to incomplete data, missing case notes or exclusion criteria.

CONCLUSION

Intra-cuff alkalinized lidocaine significantly attenuated the severity of POST, cough, hoarseness and laryngeal spasm especially in the early post-operative period, as compare to intra-cuff ketamine.

CONFLICT OF INTEREST

This study has no conflict of interest to be declared by any author.

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Author:Nadeem Naqvi, Arif Iftikhar Mallhi, Ali Asgher and Umer Rafique
Publication:Pakistan Armed Forces Medical Journal
Date:Apr 30, 2021
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