| CTRI Number |
CTRI/2024/10/075764 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate postoperative recovery time from general anesthesia in patients undergoing elective surgeries in two different anesthetic depth groups. |
|
Scientific Title of Study
|
THE EFFECT OF QCON INDEX MONITORING VERSUS END TIDAL SEVOFLURANE MONITORING ON THE TRACHEAL EXTUBATION TIME. A COMPARATIVE STUDY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Linah Maryam |
| Designation |
Post graduate student |
| Affiliation |
Acharya Shri Chander College of Medical Sciences hospital |
| Address |
Department of anesthesia
Acharya Shri Chander College of Medical Sciences Hospital Jammu
Jammu and Kashmir
Jammu
JAMMU & KASHMIR
180017
India |
| Phone |
9541886960 |
| Fax |
|
| Email |
drlonelinah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shikha sharma |
| Designation |
Professor of department of anethesia |
| Affiliation |
Acharya Shri Chander College of Medical Sciences hospital |
| Address |
Department of anesthesia
Acharya Shri Chander College of Medical Sciences Hospital Jammu
Jammu and Kashmir
Jammu
JAMMU & KASHMIR
180017
India |
| Phone |
9419184790 |
| Fax |
|
| Email |
shikha_2527@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Linah Maryam |
| Designation |
Post graduate student |
| Affiliation |
Acharya Shri Chander College of Medical Sciences and hospital |
| Address |
Department of anesthesia
Acharya Shri Chander College of Medical Sciences and Hospital Jammu
Jammu and Kashmir
JAMMU & KASHMIR
180017
India |
| Phone |
9541886960 |
| Fax |
|
| Email |
drlonelinah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Shri Chander College of Medical Sciences and hospital Jammu, Jammu and kashmir India Pincode 180017 |
|
|
Primary Sponsor
|
| Name |
Acharya Shri Chander College of Medical Sciences AND HOSPITAL jammu |
| Address |
Acharya Shri Chander College of Medical Sciences AND HOSPITAL JAMMU SIDRA India Pincode 180017 |
| Type of Sponsor |
Private 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 |
| Linah Maryam |
Acharya Shri Chander College of Medical Sciences and Hospital |
Department of anesthesia and critical care 6th floor
Jammu
JAMMU & KASHMIR |
9541886960
drlonelinah@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASCOMS institutional ethics 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 |
| Intervention |
q CON index monitoring intraoperatively versus End tidal anesthetic gas monitoring |
CONOX monitor is attached to the forehead of the patient with a sensor and the ETAG is already part of the anesthesia workstation.
Throughout the anesthesia duration of 30 min to 3 hours.
Readings from the machines are taken ever 5 min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Elective surgeries
sevoflurane |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4
emergency surgeries
epilepsy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extubation time |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sevoflurane usage |
duration of anesthesia |
|
|
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)
|
01/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The recruitment will be conducted for patients undergoing sevoflurane-based anesthesia A hundred patients have been collected from June 2023 onwards |