| CTRI Number |
CTRI/2018/06/014384 [Registered on: 04/06/2018] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Recovery from Anaesthesia |
|
Scientific Title of Study
|
The Bailey Manoeuvre for Deep Extubation-Comparison with standard extubation technique |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena Chatrath |
| Designation |
Professor and Head |
| Affiliation |
Govt Medical College, Amritsar |
| Address |
Deptt of Anaesthesia, Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814112355 |
| Fax |
|
| Email |
drveenachatrath@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Chatrath |
| Designation |
Professor and Head |
| Affiliation |
Govt Medical College, Amritsar |
| Address |
Deptt of Anaesthesia, Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814112355 |
| Fax |
|
| Email |
drveenachatrath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikramjit Singh |
| Designation |
Junior Resident |
| Affiliation |
Department of anaesthesia |
| Address |
Deptt of Anaesthesia, Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
7889034302 |
| Fax |
|
| Email |
maan2vicky@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
Deptt of Anaesthesia, Govt Medical College, Amritsar |
| 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 Veena Chatrath |
Guru Nanak Dev Hospital, Majitha Road, amritsar |
Department of Anaesthesia
Amritsar
PUNJAB |
9814112355
drveenachatrath@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA grade 1 and II, (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I gel |
I gel inserted before extubation |
| Intervention |
I gel |
This is comparison between standard extubation with that of after putting I gel when the patient is deep |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 20-60 years.
2. Patients with ASA Grade I and II undergoing surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1 Age Less than 20 and more than 60 years
2 Hypertension
3 Morbid obesity
4 Severe Cardiac dysfunction
5 Anticipated Difficult Airway
6 Refusal by the patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes after placement of I-gel before extubation in both the groups.
- Ease of placement of I-gel.
|
0-90 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any episode of coughing/bucking and desaturation.
- Post operative sore throat.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
04/06/2018 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The aim of present study is to compare the Respiratory and Hemodynamic outcomes following exchange extubation with I-gel supra glotic airway device as compared to standard awake extubation. The patients will be divided into two groups group E (awake endotracheal extubation group) and Group S (exchange extubation with I-gel supra glotic airway device) of 30 each. Group E will undergo awake endotracheal extubation and group S will undergo exchange extubation with I-gel supra glotic airway device. The heart rate, systolic BP, diastolic BP, mean artererial pressure will be recorded before induction, end of Surgery, Just after exchange, just after extubation, 5 min after extubation, 10 min after extubation and 15 min. after extubation. The occurence of straining bucking, coughing I-gel repositioning, desaturation to <95%, presence of post-operative sore throat will also be noted. All the parameters will be observed compared and analysed |