Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia

NCT ID: NCT03833947

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2019-12-30

Brief Summary

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.

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.

Conditions

Anesthesia; Anesthesia; Adverse Effect; Anesthesia Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

lignocaine+bicarbonate

Intervention Type: DRUG

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

lignocaine with dexamethasone

Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml

Group Type: ACTIVE_COMPARATOR

lignocaine+dexamethasone

Intervention Type: DRUG

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

Interventions

lignocaine+bicarbonate

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

Intervention Type: DRUG

lignocaine+dexamethasone

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aligarh Muslim University

OTHER

Sponsor Role: lead

Responsible Party

MUAZZAM HASAN

Assistant Professor, Department of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jawaharlal Nehru Medical College

Aligarh, Uttar Pradesh, India

Countries

India

Other Identifiers

AligarhMUmzm

Identifier Type: -

Identifier Source: org_study_id