Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia

NCT03833947 | Completed Phase 4

• 1 other identifier: AligarhMUmzm
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Anesthesia; Adverse Effect; Anesthesia Intubation Complication

Keywords

Intracuff Dexamethasone; Intracuff Alkalinized lignocaine; General anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Haemodynamic stability at the time of extubation.

  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

  from start till end of surgery.

• incidence of post operative cough and sore throat

  after 1 and 24 hour post extubation

Other Outcomes (1)

• duration of surgery

  duration of surgery

Study Arms (2)

lignocaine with bicarbonate

EXPERIMENTAL

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

lignocaine with dexamethasone

ACTIVE COMPARATOR

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

Drug: lignocaine+dexamethasone

Interventions

lignocaine+bicarbonate DRUG

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

lignocaine with bicarbonate

lignocaine+dexamethasone DRUG

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

lignocaine with dexamethasone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aligarh Muslim University: lead

Study Sites (1)

Jawaharlal Nehru Medical College

Aligarh, Uttar Pradesh, 450331, India

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anaesthesiology

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 7, 2019
• Study Start: March 15, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

IN (1)