A clinical trial to study the effect of nebulized lignocaine and ketamine in reducing incidence ofpostoperative sore throat

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/10/037492
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

**Introduction**

Post-operative sore throat (POST) occurs in 21-65% of patients receiving general anaesthesia (GA) with tracheal intubation. (1,2) Post operative sore throat is an unavoidable complication of general anaesthesia. Localised trauma to the mucosa during laryngoscopy and intubation leads to aseptic inflammation of the pharyngeal mucosa leading to post-operative sore throat. It may lead to minor throat irritation, debilitating pain, inability to swallow and may even cause temporary voice changes.(3) Many non-pharmacological and pharmacological methods have been tried to reduce the incidence and severity of post-operative sore throat. Using a small sized endotracheal tube, gentle laryngoscopy and intubation, maintaining cuff pressures not more than 18-20cmH2O, and local anaesthetics, steroids, NSAIDs, benzydamine gargle, ketamine gargle are some of the methods used. Ketamine, a phencyclidine derivative, has been used as a gargle or nebulization in the attenuation of post-operative sore throat by its action on peripheral NMDA receptors.4,5,6. Nebulization of lignocaine can achieve highly effective anesthesia from the oral cavity up to trachea for intubation. Here in our study we want to compare the effects of nebulized ketamine and nebulized lignocaine in reducing incidence of post operative sorethroat in pateints undergoing Elective surgeries under general anaesthesia in supine position.

**Methodology**

The present study will be conducted after receiving approval by the Institutional Ethics Committee of our hospital and written informed consent will be taken from patients. Patients will be randomly allocated in three groups by chit method. Group K ( n=40), Group L ( n= 40) and Group C (n=40). The chits will be opened by the Anaesthesiologist who is not a part of study, and nebulisation solution will be prepared according to group allocation. Group L will receive lignocaine 4% nebulization( 2ml lignocaine 4% + 3ml saline) and Group K will receive ketamine 50 mg (1.0 ml + 4.0 ml of the saline) nebulization and Group C will receive 5ml saline nebulization - 15 min prior to induction in pre op room. Patients will be blinded to the study drug used. HR, MAP, SPO2 will be recorded during nebulization. A uniform anaesthetic technique will be used to induce General anaesthesia facilitating intubation using vecuronium as muscle relaxant in both the groups. The intra-operative monitoring will include continuous electrocardiography, noninvasive blood pressure, pulse oximetry , and end-tidal carbon dioxide. At the completion of

surgery, with the patient adequately anaesthetised, the oropharynx will be gently suctioned using gentle suction catheter. Extubation will be done after reversal on return of spontaneous ventilation. Patients will be assessed post operatively for sore throat using a four point scale.

POST was graded on a four-point scale (0-3) (7)

0 = no sore throat

1 = mild sore throat (complains of sore throat only on asking)

2 = moderate sore throat (complains of sore throat on his/her own)

3 = severe sore throat (change of voice or hoarseness, associated with throat pain).

Other side-effects, if any will be noted. IV tramadol 50mg 8hrly used for post operative pain.

**SORE THROAT SCORE**

| | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

|**SORE THROAT SCORE**

**0 HR**

**1 hr**

**2 HR**

**4 HR**

**8 HR**

**12 HR**

16 HR

24 hr



|**GROUP** **K**

|**GROUP** **L**

|**GROUP C**

**References:**

1. Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory

surgery. Br J Anaesth. 2002;88:582–4. [PubMed: 12066737]

2. Loeser EA, Bennett GM, Orr DL, Stanley TH. Reduction of postoperative sore

throat with new endotracheal tube cuffs. Anesthesiology. 1980;52:257–9.

[PubMed: 7369513]

3. Zuccherelli L. Post operative upper airway problems – Review article. SAAJA.

2003(9):12-6.

4. Patel MP, Patel HH, Roth DM. general anesthetics and therapeutic gases. In:

Goodman and Gilman’s The pharmacological basis of therapeutics. 12th edition.

Edited by Brunton LL, Chabner BA, Knollman BC 2011; chapter 19: 502-539

5. Stoelting RK, Hillier SC. Intravenous sedatives and hypnotics, In:

Pharmacology and Physiology in Anaesthetic Practice. 5th edition. Edited by

Stoelting RK, Hillier SC 2014; chapter 5: 186-93.

6. Vuyk J, Sitsen E, Reekers M. Intravenous anesthetics. In: Miller’s Anesthesia.

8th ed. Edited by Miller RD, Eriksson LI, Fleisher LA:Philadelphia, Elsevier.

2015, 845-848.

7. Canbay O, Celebi N, Sahin A, Celiker V , Ozgen S, Aypar U. Ketamine gargle

for attenuating postoperative sore throat. Br J Anaesth. 2008;100:490–3.

[PubMed: 18310675]

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-25
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients with American Society of Anesthesiologists (ASA) class I or class II physical status.

Exclusion Criteria

• Patient refusal , 2.
• Pateints with ASA physical status III & IV, 3.
• History of allergic reactions to local anaesthetics or ketamine, 4.
• Patient with anticipated difficult intubation, 5.
• Duration of intubation more than 30s or more than 1 attempt of intubation, 6.
• Patients undergoing oral, head and neck surgeries, 7.
• Duration of surgery> 2hr.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of sore throat in first 24	Sore throat monitoring and grading will be done | at 0,1, 2, 4, 8, 12, 16 and 24 hours post-extubation by | an anaesthetist not aware of the group of patients
hours of post operative period	Sore throat monitoring and grading will be done | at 0,1, 2, 4, 8, 12, 16 and 24 hours post-extubation by | an anaesthetist not aware of the group of patients

Secondary Outcome Measures

Name	Time	Method
To report any complication or side effect due to nebulization of lignocaine and ketamine if seen	Monitoring will be done at 0, 2, 4, 8, 12, and 24

Trial Locations

Locations (1)

Ground floor OT Comlex, Department of Anaesthesiology, Maharaja Yeshwant Rao Hospital; 🇮🇳 Indore, MADHYA PRADESH, India

Ground floor OT Comlex, Department of Anaesthesiology, Maharaja Yeshwant Rao Hospital

🇮🇳Indore, MADHYA PRADESH, India

Deepali Valecha

Principal investigator

9424405405

deepalisidhwani@gmail.com