| CTRI Number |
CTRI/2024/07/070615 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two general anaesthesia reversal and extubation technique after surgery. |
|
Scientific Title of Study
|
A pragmatic, observational study of machine-delivered pressure-support and reservoir bag-based manual weaning and extubation following general anaesthesia |
| 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 Ankita Medhi |
| Designation |
Post Graduate Trainee |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Department of Anesthesiology, Critical Care and Pain Medicine, 2nd floor, Near ICU and OT complex, AIIMS Guwahati, Assam- 781101
Kamrup
ASSAM
781101
India |
| Phone |
8761904797 |
| Fax |
|
| Email |
ankitamedhigmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Habib Md Reazaul Karim |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Room 2049, 2nd Floor, Near OT and ICU Complex, AIIMS Guwahati, Changsari, Assam. PIN-781101
Kamrup
ASSAM
781101
India |
| Phone |
9612372585 |
| Fax |
|
| Email |
drhabibkarim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Habib Md Reazaul Karim |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Room 2049, 2nd Floor, Near OT and ICU Complex, AIIMS Guwahati, Changsari, Assam. PIN-781101
ASSAM
781101
India |
| Phone |
9612372585 |
| Fax |
|
| Email |
drhabibkarim@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Guwahati, Assam, India. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Guwahati |
| Address |
All India Institute of Medical Sciences, Silbharal, Changsari, Kamrup, Assam, pincode: 781101 |
| 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 Ankita Medhi |
All India Institute of Medical Sciences, Guwahati |
Operating Room and Recovery Area, Second Floor, OT Complex
Kamrup
ASSAM |
8761904797
ankitamedhigmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Guwahati |
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 |
This is an observational study |
| Comparator Agent |
NIL |
This is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA-PS I-III
BMI 18.5 – 29.99 kg/m2
Both male and female
Non-cardiac surgeries
Elective surgeries
|
|
| ExclusionCriteria |
| Details |
Obstetric patients
Patients on vasoactive drug infusion for hypertensive crisis or shock
Double lumen tube use
Patients not extubated on table
Anaesthesia duration less than 60 min and more than 300 min
A special group of patients
Any deviation or alternative technique of extubation if employed
Patients requiring more than 3 units of PRBC transfusion
Patients having eGFR less than 60 mL per min
Known case of COPD GOLD class 3 and above
Smoking 20 cigarettes per day in the past 48 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coughing and bucking severity |
Baseline, Extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic variations like blood pressure, mean arterial pressure, heart rate, EtCO2, minute ventilation |
At 1, 3, 5, 7 and 10 min of reversal administration.
And at 5, 10, 15, 20, 25 and 30 min of extubation |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "154"
Final Enrollment numbers achieved (India)="154" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
While research for reducing emergence coughing and bucking during anesthesia reversal and extubation has been well studied, most of the studies are done for preventing the emergence coughing and bucking by using different medications and endotracheal tube management. PS-based weaning is widely practiced in critical care and is an age-old technique now commonly practiced in the operation theatre. However, our basic search in PubMed on 30th April 2024 did not find a direct comparison between the two methods.
Aim: This study compares the emergence characteristics of general anaesthesia after reservoir bag-based weaning with pressure support-based weaning following surgery with endotracheal intubation.
Primary objective: To compare the incidence and severity of coughing and bucking during anesthesia emergence among the two groups
Hypothesis: Pressure support-based weaning might have smoother emergence characteristics than Reservoir bag-based weaning and extubation in patients undergoing general anesthesia reversal.
This is an observational study, no intervention will be done. Data will be collected. |