| CTRI Number |
CTRI/2022/06/043377 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
16/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of betamethasone gel versus lignocaine jelly for lubrication of the endotracheal tube on postoperative sorethroat,cough and hoarseness of voice and hence find a better agent to reduce the occurrence of postoperative airway complications thereby reducing morbidity |
|
Scientific Title of Study
|
A randomized interventional prospective study on comparison of betamethasone gel versus lignocaine jelly applied on endotracheal tube to reduce the occurrence of postoperative airway complications in patients undergoing surgeries under general anesthesia at SMS medical college, during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Jain |
| Designation |
Associate Professor |
| Affiliation |
SMS medical college and attached hospital |
| Address |
Department of anaesthesiology,SMS medical college and attached hospitals, Adarsh nagar Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9309482150 |
| Fax |
|
| Email |
aiims.priyanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jain |
| Designation |
Associate Professor |
| Affiliation |
SMS medical college and attached hospital |
| Address |
Department of anaesthesiology,SMS medical college and attached hospitals, Adarsh nagar Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9309482150 |
| Fax |
|
| Email |
aiims.priyanka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Raj |
| Designation |
Junior resident |
| Affiliation |
SMS medical college and attached hospital |
| Address |
Department of anaesthesiology,SMS medical college and attached hospitals,Adarsh nagar Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8921633424 |
| Fax |
|
| Email |
aparnaraj686@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,SMS Medical college and Attached Hospitals |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical college and Attached Hospitals |
| Address |
JLN Marg Adarsh Nagar Jaipur Pin 302004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Jain |
SMS Medical College and Attached Hospitals |
Department of Anaesthesiology Second floor Dhanvantri OPD block JLN Marg Adarsh Nagar Jaipur Pin 302004
Jaipur
RAJASTHAN |
9309482150
aiims.priyanka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betamethasone gel 0.05% |
lubrication of the endotracheal tube before intubation |
| Intervention |
lignocaine jelly 2% |
lubrication of the endotracheal tube before intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of ASA grade I and II
2.Patients undergoing elective surgery requiring endotracheal intubation (Duration less than 3 hours) |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study
2.Surgeries of oral cavity and pharynx
3.Anticipated difficult airway
4.More than 2 attempts at intubation
5.Use of nasogastric or orogastric tube perioperatively
6.Patients with upper respiratory tract infection
7.Patients on steroids |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cases with postoperative sore throat |
1,6,12 and 24 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cases with postoperative cough and hoarseness of voice |
1,6,12 and 24 hours after extubation |
| Occurrence of laryngospasm,bronchospasm |
during and after extubation |
| Hemodynamic parameters HR,SBP,DBP,MAP |
baseline,before intubation,after intubation every 5 min till 15 minutes,then every 15 min upto 120 minutes,at reversal of neuromuscular block,at the time of extubation,every 2 min till 8 minutes,then every 5 min upto 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative sore throat,cough and hoarseness of voice are common uncomfortable distressing sequelae following endotracheal intubation.Various strategies have been employed to attenuate the extubation response .In this study we want to compare the effectiveness of lubricating the endotracheal tube with betamethasone(0.05 %) with lignocaine jelly(2%) on post operative airway complications at 1,6,12 and 24 hrs ,the occurrence of extubation related adverse effects and on intraoperative hemodynamic parameters. |