NCT07256834

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

November 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2025

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

14 days

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative sore throat

    Comparing presence and grading of sore throat in both arms after endotracheal intubation.

    Sore throat after endotracheal intubation at 6 hrs and 24hrs post operatively. Sample completion in 2 weeks

Study Arms (2)

Group A receiving betamethasone gel during endotracheal intubation

ACTIVE COMPARATOR

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

Drug: Betamethasone dipropionate 0.05%

Group B receiving lidocaine gel during endotracheal intubation

ACTIVE COMPARATOR

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

Drug: Lidocaine hydrochloride 2%

Interventions

It is corticosteroid indicated for relief of inflammatory and pruritic manifestation

Group A receiving betamethasone gel during endotracheal intubation

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

Group B receiving lidocaine gel during endotracheal intubation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years
  • Either gender
  • ASA I to II
  • Patients planned for elective surgery under general anesthesia not lasting more than 4 hours.

You may not qualify if:

  • Patients requiring more than 2 attempts for successful intubation
  • Patients undergoing surgeries of oral cavity or pharynx
  • Mallampati Score of 3 or 4
  • Patients with upper respiratory tract infection
  • Patients already taking steroids
  • Use of nasogastric tube perioperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

November 22, 2025

Primary Completion

December 6, 2025

Study Completion

December 6, 2025

Last Updated

December 1, 2025

Record last verified: 2025-11