Comparison of Efficacy of Betamethasone Gel With Lidocaine Gel in Prevention of Post Endotracheal Intubation Sore Throat.

NCT ID: NCT07256834

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-22
• Study Completion Date: 2025-12-06

Brief Summary

The goal of this clinical trial is to compare the incidence of postoperative sore throat in adult patients of either gender belonging to ASA I or II ,undergoing endotracheal intubation using betamethasone gel versus lidocaine gel. It aims to determine

1: Difference in efficacy of Betamethasone gel and lidocaine gel in prevention of post operative sore throat after endotracheal intubation.

Patients will be assessed for the presence of a sore throat at 6 hours and 24 hours postoperatively. The severity of the sore throat will be graded using the Post-Operative Sore Throat (POST) score.

Detailed Description

This study aims to resolve the debate over the superiority of betamethasone versus lidocaine in preventing POST. Achieving clarity on this issue will not only reduce patient morbidity but also help decrease the duration of hospital stays and lower hospital bed occupancy.The study will commence following the approval of the synopsis by the Research Department of the College of Physicians and Surgeons, Pakistan (CPSP). All patients scheduled for elective surgery under general anesthesia who fulfil the inclusion criteria will be included in the study from Jinnah Postgraduate Medical Center (JPMC). Informed written consent will be obtained from the patients prior to their inclusion in the study.

Initial data, including name, date of presentation, age, weight, height, BMI and gender will be recorded on a predesigned proforma. Patients will then be divided into two group (A and B) through simple random sampling software. In Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube. In Group B patients, lubrication will be done in a similar manner using 2.5ml of 2% Lidocaine gel. After induction of anesthesia (with IV Propofol 2.5mg/kg, Nalbuphine 0.1mg/kg, Atracurium 0.5mg/kg) and 3 minutes of bag mask ventilation, trachea will be intubated with endotracheal tube of size 7 or 7.5mm according to internal diameter of trachea. Successful endotracheal intubation will be confirmed by capnography and bilaterally equal air entry. Maintenance of general anesthesia will be done by Isoflurane and 60% oxygen mixed with compressed air. Upon completion of surgery, Isoflurane will be discontinued, and residual neuromuscular blockage will be antagonized by Neostigmine 0.05mg/kg. The trachea will be extubated after the patient is fully awake. All patients will be shifted to post-anesthesia care unit where standard ASA monitoring will be continued by a team of anesthetists. The presence and grading of Postoperative sore throat will be done by researcher himself, according to POST Scores at 6 and 24 hours postoperatively, in presence of consultant anesthetist of 5 years of experience. The study will be relevant and specific towards its objective and proper exclusion criteria will be used to control any bias / confounders.

Conditions

Post Operative Sore Throat at 6hrs and 24hrs After Endotracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A receiving betamethasone gel during endotracheal intubation

Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube

Group Type: ACTIVE_COMPARATOR

Betamethasone dipropionate 0.05%

Intervention Type: DRUG

It is corticosteroid indicated for relief of inflammatory and pruritic manifestation

Group B receiving lidocaine gel during endotracheal intubation

Group B patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 2% Lidocaine gel, from distal end of cuff to 15cm mark on endotracheal tube

Group Type: ACTIVE_COMPARATOR

Lidocaine hydrochloride 2%

Intervention Type: DRUG

It is amide local anesthetic used for lubrication and pain prevention as topical anesthetic regimen

Interventions

Betamethasone dipropionate 0.05%

It is corticosteroid indicated for relief of inflammatory and pruritic manifestation

Intervention Type: DRUG

Lidocaine hydrochloride 2%

It is amide local anesthetic used for lubrication and pain prevention as topical anesthetic regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18-60 years

2. Either gender

3. ASA I to II

4. Patients planned for elective surgery under general anesthesia not lasting more than 4 hours.

Exclusion Criteria

1. Patients requiring more than 2 attempts for successful intubation

2. Patients undergoing surgeries of oral cavity or pharynx

3. Mallampati Score of 3 or 4

4. Patients with upper respiratory tract infection

5. Patients already taking steroids

6. Use of nasogastric tube perioperatively

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

F.2-81/2025-GENL/429/JPMC

Identifier Type: -

Identifier Source: org_study_id