A study in adult surgical patients to find out what causes sore throat after surgery and whether keeping breathing tube pressure at safe levels can help reduce it.

Not yet recruiting

• Conditions: Pain in throat,

• Registration Number: CTRI/2025/05/087382
• Lead Sponsor: Bhaktivedanta Hospital and Research Institute

Brief Summary

Postoperative sore throat (POST) is a common complication after general anaesthesia, often due to mucosal injury from airway devices, leading to discomfort and delayed recovery. This study aims to evaluate the relationship between perioperative factors and POST, and whether maintaining endotracheal tube cuff pressures between 20–30 cm H2O and supraglottic airway device pressures up to 60 cm H2O reduces its incidence. Adult patients over 18 years undergoing surgeries under general anaesthesia with ASA Grade 1 or 2 status will be included, while those with pre-existing throat conditions, undergoing specific throat surgeries, or requiring postoperative ventilation will be excluded. Patients will be divided into two groups: one with continuous cuff pressure monitoring and one with standard practice. The study will record demographics, medical history, anaesthesia details, and postoperative outcomes over one year with a total sample size of 50 patients. The primary endpoint is to compare the incidence of POST between the two groups, and the secondary endpoint is to assess the influence of perioperative variables on POST occurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-06
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All patients of all genders above 18 years of age 2.
• Patients who are schedule for surgery and require general anaesthesia with use of either endotracheal tube or supraglottic airway device.
• All ASA Grade 1 and ASA Grade 2 patients included.
• (ASA= American Association of Anaesthesiologists).

Exclusion Criteria

• Patient with pre-existing sore throat due to vocal cord polyp or vocal cord growth or oral-throat cancerous growth / thyroid swelling/ tonsillitis/ no reason 2.
• Patients undergoing following surgeries, not be included- Micro-laryngoscopy or DL scopies for vocal cord polyp or growth and Oral-Throat cancer surgeries 3.
• Drowsy patient / Patients with poor General Condition/ Mentally challenged were excluded 4.
• Patients who required postoperative ventilator or who were shifted on T-piece excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparison of postoperative sore throat (POST) incidence between Group A, where cuff pressure is actively monitored, and Group B, which follows standard practice without cuff pressure monitoring.	within 24 hours and at the time of discharge

Secondary Outcome Measures

Name	Time	Method
To assess the relationship between key perioperative variables (such as intubation time, tube size, and anesthesia management) and the occurrence of postoperative sore throat (POST) in both groups.	after one year

Trial Locations

Locations (1)

Bhaktivedanta Hospital and Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

Bhaktivedanta Hospital and Research Institute

🇮🇳Thane, MAHARASHTRA, India

Dr Shilpa Tiwaskar

Principal investigator

9820067137

drtiwaskar@gmail.com