Clinical trial NCT03833947: Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia
Official title: Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Anesthesia; Adverse Effect
Anesthesia Intubation Complication
Keywords: Intracuff Dexamethasone
Intracuff Alkalinized lignocaine
General anesthesia
Lead sponsor: Aligarh Muslim University
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: smoothness of extubation
timeFrame: 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.
measure: patient satisfaction score
timeFrame: post operative 1 hour
Secondary outcomes:
measure: Haemodynamic stability at the time of extubation.
timeFrame: values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation
measure: amount of drug diffused through endotracheal tube cuff
timeFrame: from start till end of surgery.
measure: incidence of post operative cough and sore throat
timeFrame: after 1 and 24 hour post extubation
Other outcomes:
measure: duration of surgery
timeFrame: duration of surgery
Locations:
city: Aligarh
country: India
facility: Jawaharlal Nehru Medical College
state: Uttar Pradesh
Study officials:
References: