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NCT Number: NCT07315490

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

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.

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Key information

Conditions

Postoperative Sore Throat, Cough, Hoarseness Cough Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Stomatognathic Diseases Voice Disorders

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Liaquat

Islamabad, Federal Capital, 44800, Pakistan

About this study

Every patient will be evaluated in the preoperative clinic where detailed present and past history including any current illness, medication, previous surgeries and addiction will be taken and recorded. Also baseline investigations will be evaluated. Airway examination and Mallampati scoring will be done. The patients will be divided into 2 groups: Group A (Air) and Group X (Xylocaine plain 2%), using air and Xylocaine for alternate patients.

In the OT, an anesthesia resident will record baseline vitals. An IV line with 18 or 20 G cannula will be secured and IV fluid Ringer Lactate will be infused according to the body weight. All patients will be preoxygenated for 3min. Patients will be premedicated Ondansetron 0.8mg/kg, Glycopyrrolate 0.2mg/kg, Dexamethasone 8mg, inducted with Propofol 2mg/kg, Atracurium 0.5mg/kg. Anesthesia will be maintained with Oxygen 50%, Nitrous oxide 50% and Isoflurane. Patient will be intubated with a cuffed ETT, size 7 or 7.5 mm for males and 6.5 or 7mm for females. For Group A the cuff of the ETT will be inflated with air and for Group X the ETT cuff will be inflated with Xylocaine plain 2% and the ETT cuff pressure will be measured by an anesthesia assistant using cuff manometer immediately after intubation and at 5, 15, 30min and then at every 30 min till the completion of surgery.

On completion of surgery, anesthesia will be reversed by weaning of the anesthetic gases and neostigmine 0.05-0.07mg/kg with glycopyrrolate will be used to reverse the remaining muscle paralysis. When the patient is awake the ETT cuff will be deflated by removing the inflating agent. Then the patient will be oxygenated with a face mask until needed. Signs and symptoms like postoperative sore throat, cough and hoarseness of voice will be recorded immediately after extubation and at 30min, 6hr and 24 hr post operatively. The severity of POST will be scored on a scale of 0-3 (0: No POST; 1: Mild; 2: Moderate; 3: Severe).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Measurement of ETT cuff Pressure

    Time frame: From the time of intubation till extubation

    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

  2. Postoperative Sorethroat, Cough and Hoarseness

    Time frame: From extubation till 24 hours postoperatively

    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)

Secondary outcomes

  1. Demographic data

    Time frame: From enrollment till 24 hours postoperatively

    Age: can affect airway anatomy (loss of elasticity, missing or loose teeth) BMI: higher malampatti scores, difficult intubation (kg/m²) Gender: structural airway differences, different ETT sizes Difficulty of intubation: directly related to airway trauma Duration of surgery: directly related to increase in cuff pressures in N2O anesthesia (in minutes) ASA physical status: according to classification given by Amercian Society of Anesthesiologists, will be done preoperatively.

Sponsors and collaborators

Lead sponsor

PAEC General Hospital, Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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