| CTRI Number |
CTRI/2024/10/075762 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison changes in patient confusion assessment methods in two ways of anesthetic depth monitoring.
The participants involved are patients undergoing elective non-emergent surgeries. The main outcome would be the detection of delirium. |
|
Scientific Title of Study
|
THE EFFECT OF QCON INDEX MONITORING VERSUS END TIDAL SEVOFLURANE MONITORING ON 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 and Hospital Jammu |
| Address |
Department of anesthesia
Acharya Shri Chander College of Medical Sciences and Hospital Jammu and sidra
Jammu
JAMMU & KASHMIR
180017
India |
| Phone |
9541886960 |
| Fax |
|
| Email |
drlonelinah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shikha Sharma |
| Designation |
Professor Department of Anethesia |
| Affiliation |
Acharya Shri Chander College of Medical Sciences and Hospital |
| Address |
Acharya Shri Chander College of Medical Sciences and Hospital Jammu and sidra
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 and sidra
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 India pincode 180017 |
|
|
Primary Sponsor
|
| Name |
Acharya Shri Chander College of Medical Sciences AND HOSPITAL |
| Address |
Acharya Shri Chander College of Medical Sciences AND HOSPITAL SIDRA JAMMU 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 6th floor
Jammu
JAMMU & KASHMIR |
9541886960
drlonelinah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASCOMS INTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
going for elective surgieries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4
other inhalational agents
emergency surgeries
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Delirium Assessment by confusion assessment method score (CAM Score) |
baseline and post-operative time zero |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ETAG Group and qCON group |
score |
|
|
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
|
Background: Anesthetic depth monitoring can be done in various ways, the first way is by end-tidal anesthetic depth monitoring and another way is using EEG by qCON index from CONOX Monitor. In this study, we will compare the CAM ( Confusion assessment method score) score pre and post-operatively, to see symptoms of delirium in both groups. This is the main purpose; Delirium assessment by CAM score.
|