Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia

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

Study Overview

• Status: Completed
• Conditions: Anesthesia; Anesthesia Intubation Complication; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: lignocaine+bicarbonate; Drug: lignocaine+dexamethasone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Uttar Pradesh
    • Aligarh, Uttar Pradesh, India, 450331
      • Jawaharlal Nehru Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lignocaine with bicarbonate; Endotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml	Drug: lignocaine+bicarbonate; ETT cuff was filled with mixture of 2% lignocaine with bicarbonate
Active Comparator: lignocaine with dexamethasone; Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml	Drug: lignocaine+dexamethasone; ETT cuff was filled with mixture of 2% lignocaine with dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
smoothness of extubation	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.	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.
patient satisfaction score	rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely	post operative 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic stability at the time of 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.	values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation
amount of drug diffused through endotracheal tube cuff	Volume of drug mixture in the cuff was noted at start and end of surgery.	from start till end of surgery.
incidence of post operative cough and sore throat	incidence of post operative cough and sore throat	after 1 and 24 hour post extubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of surgery	duration of surgery	duration of surgery

Collaborators and Investigators

• Sponsor: Aligarh Muslim University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: General anesthesia; Intracuff Dexamethasone; Intracuff Alkalinized lignocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexamethasone; Lidocaine
• Other Study ID Numbers: AligarhMUmzm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No