| CTRI Number |
CTRI/2023/04/051929 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of extubation on wound pain in supine position and 30 degree head end elevated position |
|
Scientific Title of Study
|
Comparative evaluation of the effect of extubation on wound pain in supine position and semi fowler position |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navkirat Singh |
| Designation |
PG junior resident Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital , Faridkot |
| Address |
Department of anaesthesiology, GGSMCH, Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9815376028 |
| Fax |
|
| Email |
navkiratsandhu199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kewal Krishan Gupta |
| Designation |
Associate professor, Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot. |
| Address |
Department of anaesthesiology, GGS Medical College and Hospital, Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9781812052 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kewal Krishan Gupta |
| Designation |
Associate professor, Department of Anaesthesiology |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot. |
| Address |
Department of anaesthesiology, GGS Medical College and Hospital, Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9781812052 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, GGSMCH, Faridkot |
|
|
Primary Sponsor
|
| Name |
Dr Kewal Krishan Gupta |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot. |
| Type of Sponsor |
Other [Other [self]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amandeep Singh |
Department of Surgery, GGSMCH, Faridkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NAVKIRAT SINGH |
GGS medical college and Hospital |
Department of Anaessthesiology, GGS Medical College and Hospital Faridkot,
Punjab
Faridkot
PUNJAB |
9815376028
navkiratsandhu199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of GGS medical college abd hospital Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal extubation in Semifowler position |
To evaluate the effect of extubation in Semifowler position on surgical pain |
| Comparator Agent |
Routine endotracheal extubation in supine position |
To evaluate effect of endotracheal extubation in supine position on surgical pain |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA grade I and II
Patients age between 18-65 years of either gender giving valid informed and written consent
Patients undergoing abdominal surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with
Difficult airways
Obesity BMI more than 35
Symptomatic reflux disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surgical pain intensity using VAS |
At 5 minutes, 15 minutes, 30 minutes, and 60 minutes after extubation time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, Blood pressure, Arterial Saturation |
Baseline, 5 minutes, 15 minutes, 30 minutes and 60 minutes postoperatively |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
10/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [navkiratsandhu199@gmail.com].
- For how long will this data be available start date provided 02-12-2024 and end date provided 02-12-2029?
Response (Others) - 5 years till study is completed
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Extubation has been linked with various complications like coughing , bucking, laryngospasm and haemodynamic instability. Coughing and bucking during extubation raises intra-abdominal pressure and aggravates patient discomfort and can cause increased wound pain in patients undergoing abdominal surgeries. To avoid these complications various positions for extubation has been tried , one such position is Semi Fowler position in which head end of the bed is elevated by 30 degrees, this position may help to lessen the intensity of a surgical wound and abdominal pain by reducing abdominal muscle tension.Therefore we hypothesized that the extubation in semi fowler position might be associated with decreased incidence of wound pain after abdominal surgeries as compared to the patients extubated in supine position. |