Air Versus Lignocaine for Endotracheal Tube Cuff Inflation and Effect on Postoperative Sore Throat and Intracuff Pressure

NCT07315490 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PGHI-IRB (DMe)-RCD-06-096
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal Tube (ETT) is frequently used for GA (general anesthesia) to deliver oxygen and volatile anesthetic agents to the patient and serves as a channel for anesthetic gases. The ETT cuff helps in positive pressure ventilation and maintains an adequate seal between the endotracheal tube and trachea. Prolonged inflation of ETT cuff can cause ischemic changes of tracheal mucosa and other complications like postoperative sore throat (POST), hoarseness of voice, difficulty in swallowing, tracheal wall ulcer, stricture etc. Among these, the occurrence of sore throat after GA ranges from 21 - 65% Hence it important to measure ETT cuff pressure in intubated patients. The reliable and convenient way for this is using an ETT manometer, which is not readily available in most of hospitals in Pakistan.Many studies have focused on incidence of POST. Most of these studies have been done in western population and differences in various ethnicities are well reported . In Pakistan, air is widely used for ETT cuff inflation. If the results depict minimal cuff pressure changes and postoperative side effects with Xylocaine as compared to air, then it can be inferred that cuff pressure does not increase due to N2O when Xylocaine is used, hence, it can be safely used for cuff inflation eliminating the requirement of ETT cuff pressure monitoring and also the ETT cuff manometer, serving as a cost-effective alternative.

Conditions

Postoperative Sore Throat, Cough, Hoarseness

Keywords

Endotacheal Tube; General Anesthesia; Air; ETT cuff; Xylocaine; Post operative sore throat; ETT cuff Manometer; Cough; Sore throat; Hoarseness of voice; Intra cuff pressure

Outcome Measures

Primary Outcomes (2)

• Measurement of ETT cuff Pressure

  Patients will be divided in 2 groups on basis of the medium used for ETT cuff infalation (Air or Xylocaine) and intracuff pressure will be measured using ETT cuff manometer immediately after intubation, at 5min, 15min, 30min and then eveey 30 min till completion of surgery

  From the time of intubation till extubation

• Postoperative Sorethroat, Cough and Hoarseness

  This will be measured immediately after extubation, at 30min, 6hrs and 24 hours postoperative using POST (postoperative sorethroat) scoring scale for both groups of subjects and responses will be compared. Sorethroat (grade 0-3; where 0 stand for no sorethroat and 3 stand for severe sorethroat) Cough (grade 0-3; where 0 stand for no cough and 3 stand for severe cough) Hoarseness of Voice (grade 0-3; where 0 stand for no hoarseness and 3 stand for severe hoarseness)

  From extubation till 24 hours postoperatively

Secondary Outcomes (1)

• Demographic data

  From enrollment till 24 hours postoperatively

Study Arms (2)

Xylocaine

EXPERIMENTAL

In 50% of subjects undergoing surgeriws under GA, Xylocaine will be used for ETT cuff inflation. Intracuff pressures will be measured every 15 mins using ETT cuff manometer and compared with intracuff air.Postoperative POST scoring will be done to study its effect on postopertaive sorethroat and incidence will weighed against intracuff air.

Drug: Xylocaine

Air

PLACEBO COMPARATOR

In 50% of subjects undergoing surgeries under GA, air will be ussed for ETT cuff inflation, intracuff pressures will be measured every 15 min POST scoring will be done postoperatively.

Drug: Xylocaine

Interventions

Xylocaine DRUG

In patients undergoing surgeries under GA, xylocaine will be used for 50% subjects and ETT cuff pressures will be measured at regular and compated to air to study if using xylocaine can abolish the affect of Nitrous oxide on intracuff air pressure. Also postoperatively, POST scoring will be done.

Air; Xylocaine

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anaesthesiologists) I and II
• Male/Female
• Age group 18 - 55 years
• Patient undergoing surgery under general anesthesia.
• Patients undergoing surgery in supine/ Trendelenburg position.

You may not qualify if:

• ASA III and IV
• Patients with preoperative history of cough or sore throat
• Patients undergoing nose, throat, or airway surgery.
• Patients with history of allergic diseases
• Patient with known pulmonary disease
• Patients in whom more than 1 attempt on intubation is done
• Patients who may need postoperative ventilation.

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

Liaquat

Islamabad, Federal Capital, 44800, Pakistan

Location

Related Links

• Changes in endotracheal tube cuff pressures and incidence of post-operative sore throat while using different inflating agents
• Postoperative Sore Throat Following General Surgical Procedures under General Anesthesia with Endotracheal Intubation
• Effect of Air versus 1% Lignocaine used for Endotracheal Tube Cuff Inflation on Laryngotracheal Morbidity after Laparoscopic Surgery- A Randomised Clinical Study

MeSH Terms

Conditions

Cough; Hoarseness; Pharyngitis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Trainee, Department of Anesthesiology, PAEC general hospital Islamabad

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 2, 2026
• Study Start: August 2, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)