Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833947
• Other study ID #: AligarhMUmzm
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Aligarh Muslim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia Intubation Complication
• Anesthesia; Adverse Effect

Intervention

Drug:
• lignocaine+bicarbonate
ETT cuff was filled with mixture of 2% lignocaine with bicarbonate
• lignocaine+dexamethasone
ETT cuff was filled with mixture of 2% lignocaine with dexamethasone

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College	Aligarh	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Aligarh Muslim University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of surgery	duration of surgery	duration of surgery
Primary	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.
Primary	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	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
Secondary	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.
Secondary	incidence of post operative cough and sore throat	incidence of post operative cough and sore throat	after 1 and 24 hour post extubation