Skip to main content
OpenTrials
Completed

NCT Number: NCT03833947

Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia

This study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jawaharlal Nehru Medical College

Aligarh, Uttar Pradesh, 450331, India

About this study

Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.

Design and setting:

This is a prospective single blind, randomized controlled study at the department of anesthesiology, JNMCH, AMU, Aligarh.

Materials and methods:

Investigators plan to include 100 patients of age group within 18-60 years with American Society of Anesthesiologists (ASA) class I & II, posted for elective surgery of duration >120 minutes, performed under general anesthesia; administered as per institutional protocols. Patients with ASA III & IV, cardiovascular morbidities, known drug allergy, pregnancy will be excluded from the study. Patients will be divided into two groups randomly according to chit-in-box method, viz Group A & Group D with fifty patients in each group. Patient group allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned and analysis of observed data will be done by a separate anesthetist not involved in the perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5: 9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2% lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated until no leak is heard at all during the peak airway pressure of the ventilator cycle while auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end of surgery. Total duration of anesthesia will be noted.

Hemodynamic stability at the time of extubation will be meausred in terms of changes in rate pressure product (RPP) which will denote the product of heart rate and systolic blood pressure. RPP values recorded immediately after stoppage of the anesthetic agents at the end of surgery will be compared to the values measured just after the extubation of trachea. Patient's satisfaction from anesthesia given will be recorded, based on VAS. The presence of coughing and bucking will also be noted. Incidence of postoperative sore throat and cough will be recorded at 1 hour and 24 hours post extubation.

The results will be presented in number, percentage, mean, and standard deviation as appropriate. Appropriate statistical tests will be applied and P value less than 0.05 will be considered as statistically significant.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) class I & II.
  • Elective surgery
  • General anesthesia of duration >120 minutes.

Exclusion criteria

  • Patients with ASA III & IV.
  • Known Cardiovascular morbidities.
  • Pregnancy.
  • Allergic to used drugs.

Treatment and study plan

lignocaine+bicarbonate

Drug

ETT cuff was filled with mixture of 2% lignocaine with bicarbonate

lignocaine+dexamethasone

Drug

ETT cuff was filled with mixture of 2% lignocaine with dexamethasone

Primary outcomes

  1. smoothness of extubation

    Time frame: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.

    Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.

  2. patient satisfaction score

    Time frame: post operative 1 hour

    rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely

Secondary outcomes

  1. Haemodynamic stability at the time of extubation.

    Time frame: values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation

    Rate pressure product (RPP); [RPP=Product of systolic blood pressure(mmHg) and heart rate (beats per min)] measured after stopping the anaesthetic agents at the end of surgery will be taken as baseline and then compared to values measured immediately after the removal of endotracheal tube.

  2. amount of drug diffused through endotracheal tube cuff

    Time frame: from start till end of surgery.

    Volume of drug mixture in the cuff was noted at start and end of surgery.

  3. incidence of post operative cough and sore throat

    Time frame: after 1 and 24 hour post extubation

    incidence of post operative cough and sore throat

Other outcomes

  1. duration of surgery

    Time frame: duration of surgery

    duration of surgery

Sponsors and collaborators

Lead sponsor

Aligarh Muslim University

Other

Registry information

Official study title

Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Jan 3, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.