Comparing whether the use of a special tube inserted during general anaesthesia with that of regular tubes in reducing sore throat in the general public

Recruiting

Conditions: Encounter for prophylactic surgery, unspecified,

Registration Number: CTRI/2025/03/083130

Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCE MANGALAGIRI

Brief Summary: Post operative sore throat with the use of endotracheal tubes is reported to have an incidence of up to 62%. Some of the known risk factors include, female sex, young age, smokers, preexisting lung disease, blood-stained endotracheal tubes, use of double lumen tubes, intubation without neuromuscular blockade and higher cuff pressure. There were many limitations noted in the studies conducted on POST as per the various systematic reviews. There are many techniques described to reduce the incidence of POST few of which include application of lignocaine gel on the cuff, injection of intravenous lignocaine in the cuff, application of steroid cream on the cuff, use of NMDA receptor antagonists like magnesium sulphate and ketamine both IV and gargling solutions etc. Few studies have proposed that the lignocaine spray or gel might themselves cause POST due to the presence of irritant additives in them. Despite the use of all the above, still the incidence and the patient discomfort remains high.The novel adaptive cuff technology endotracheal tube were introduced recently that prevent exertion of continuous pressure on the tracheal mucosa throughout the surgery. We aim to compare the novel adaptive ETT with the routine poly vinyl chloride endotracheal tube in reducing the incidence and severity of post operative sore throat.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 120

Inclusion Criteria

ASA Physical Status of I to III Mallampati Grade of I and II Scheduled for elective surgery under general anaesthesia requiring placement of endotracheal tube Duration of surgery between 60 to 240 minutes.

Exclusion Criteria

History of recent upper respiratory tract infection or sore throat Anticipated difficult airway or those who require more than one attempt at endotracheal intubation Traumatic intubation or blood stained ETT Inability to ventilate (leaks) with the adaptive cuff tubes Preoperative use of analgesic medications (Paracetamol/NSAIDs/Opioids) within 24 hours of surgery H/O lung diseases and smoking.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To predict the incidence of sore throat in patients whom novel tube is being used	To assess for sore throat after the surgery \| Immediately at the end of anaesthesia \| At 2 hours postoperatively \| At 6 hours postoperatively \| At 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
To check for cuff pressures intraoperatively	To look for post operative nausea and vomitting

Trial Locations

Locations (1): All India Institute of Medical Science Mangalagiri
🇮🇳
Guntur, ANDHRA PRADESH, India
All India Institute of Medical Science Mangalagiri
🇮🇳Guntur, ANDHRA PRADESH, India
Eeshwar M V
Principal investigator
09740122272
eeshwar.kmc@gmail.com