| CTRI Number |
CTRI/2023/05/053081 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare extubation time with inhalational anaesthesia and intravenous anaesthesia when used for maintainence in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of Inhalational Anaesthetic Technique with Desflurane versus Propofol infusion on extubation time in patients undergoing laparoscopic cholecystectom |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha PK |
| Designation |
Post Graduduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital,New Delhi
New Delhi
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital,New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
9630242575 |
| Fax |
|
| Email |
anupayyalikka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital,New Delhi
New Delhi
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital,New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital,New Delhi
New Delhi
Department of Anaesthesia and Intensive care,Vardhman Mahavir medical college and Safdarjung hospital,New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical - |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar,New Delhi |
| 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 |
| Anusha PK |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anesthesiology and Intensive Care,Ground floor,Main OT Block,Vardhman Mahavir Medical College and safdarjung hospital
New Delhi
DELHI |
9630242575
anupayyalikka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desflurane |
Patients undergoing laparoscopic cholecystectomy will be given desflurane for maintenance of anaesthesia and extubation time will be assessed. |
| Intervention |
Propofol |
Patients undergoing laparoscopic cholecystectomy will be given propofol infusion for maintenance of anaesthesia and extubation time will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of anaesthesiologists physical status grade I and II scheduled for laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to desflurane or propofol |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare extubation time with inhalational anaesthesia using desflurane and intravenous anaesthesia using propofol when used for maintenance in laparoscopic cholecystectomy |
Time taken for extubation ie the time from switching off of maintenance agents to extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative hemodynamic parameters |
Intraoperatively every 15 minutes vital parameters will be assessed |
| Sedation score |
Postoperatively using Ramsay sedation score |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is undertaken to comparatively evaluate extubation times with desflurane inhalational anaesthesia and propofol infusion when used for maintenance of anaesthesia in patients undergoing laparoscopic cholecystectomy.Primarily extubation time will be recorded and secondarily intraoperative hemodynamic parameters and sedation score will be assessed. |