| CTRI Number |
CTRI/2024/03/063973 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Recall of extubation process |
|
Scientific Title of Study
|
General Anaesthesia and recall of discomfort on tracheal extubation: A Prospective Observational 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 |
Dr Mahima K B |
| Designation |
Assistant Professor |
| Affiliation |
MVJ Medical College & Research Hospital |
| Address |
Department of Anaesthesiology, MVJ Medical College & Research Hospital, Bangalore.
Bangalore
KARNATAKA
562114
India |
| Phone |
9620701726 |
| Fax |
|
| Email |
mahimabalakrishnaiah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahima K B |
| Designation |
Assistant Professor |
| Affiliation |
MVJ Medical College & Research Hospital |
| Address |
Department of Anaesthesiology, MVJ Medical College & Research Hospital, Bangalore.
Bangalore
KARNATAKA
562114
India |
| Phone |
9620701726 |
| Fax |
|
| Email |
mahimabalakrishnaiah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima K B |
| Designation |
Assistant Professor |
| Affiliation |
MVJ Medical College & Research Hospital |
| Address |
Department of Anaesthesiology, MVJ Medical College & Research Hospital, Bangalore.
Bangalore
KARNATAKA
562114
India |
| Phone |
9620701726 |
| Fax |
|
| Email |
mahimabalakrishnaiah@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVJ Medical College & Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr. Mahima K B |
| Address |
Assistant Professor, Department of Anaesthesiology, MVJ Medical College & Research Hospital. |
| Type of Sponsor |
Other [Self] |
|
|
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 Mahima K B |
MVJ Medical College & Research Hospital |
Department of Anaesthesiology, MVC & RH, NH-4, Kolathur post, Hoskote, Bangalore- 562114
Bangalore
KARNATAKA |
9620701726
mahimabalakrishnaiah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ Medical College & Research Hospital |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged between 20–60yrs
Posted for elective surgery under general anaesthesia
Surgery duration less than 2hours
ASA status I &II
Extubated on operating table |
|
| ExclusionCriteria |
| Details |
Emergency surgery
Surgery duration more than 2hours
Pregnant individual
Patients requiring post-op ventilation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected low frequency of recall |
24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
Final Enrollment numbers achieved (Total)= "750"
Final Enrollment numbers achieved (India)="750" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
At the time of extubation, patients often buck or move about violently, raising concerns that they are experiencing discomfort during extubation. If patients are extubated too quickly out of concern for patient discomfort without adequate evaluation, there is a risk of apnoea, aspiration and laryngospasm during extubation.In our study we are investigating the frequency of recall of discomfort on extubation. A low frequency of recall would suggest that extubation need not be rushed and may be performed on the basis of clinical judgement, despite apparent patient discomfort. |