| CTRI Number |
CTRI/2023/12/060808 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between propofol with dexmedetomidine and propofol with fentanyl for smooth induction for I-gel insertion in short surgical procedures |
|
Scientific Title of Study
|
Comparison of fentanyl and dexmedetomidine as adjuvant to propofol for i gel insertion in short surgical procedures. |
| 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 shruti singh yadav |
| Designation |
Pg resident |
| Affiliation |
Peoples college of medical sciences and research center |
| Address |
Anaesthesia department , first floor peoples hospital bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7806093137 |
| Fax |
|
| Email |
shrutisyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahima Batra |
| Designation |
Professor |
| Affiliation |
Peoples college of medical sciences and research center |
| Address |
Anaesthesia department , first floor peoples hospital bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752075418 |
| Fax |
|
| Email |
ph.anaesthsia@peoplesuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr shruti singh yadav |
| Designation |
Pg resident |
| Affiliation |
Peoples college of medical sciences and research center |
| Address |
Anaesthesia department , first floor peoples hospital bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7806093137 |
| Fax |
|
| Email |
shrutisyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples hospital, Peoples university, Bhopal, M.P., 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples hospital |
| Address |
Peoples hospital, Peoples university , Bhanpur , Bhopal, M.P., 462037 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr shruti singh yadav |
Peoples campus bhopal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr shruti singh yadav |
Peoples hospital |
Anaesthesia department , first floor , peoples hospital, Peoples university, Bhanpur, Bhopal
Bhopal
MADHYA PRADESH |
7806093137
shrutisyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples college of medical sciences and research center, Institutional Ethics Committee |
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 |
| Comparator Agent |
Dexmedetomidine |
1 microgram/kg of injection dexmedetomidine diluted to 10 ml with 0.9 % of normal saline over 10 minutes |
| Intervention |
Fentanyl |
Injection fentanyl 1 microgram/kg diluted to 5 ml with 0.9% normal saline over 2 minutes intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- age 18 years to 60 years
- ASA grade 1 and 2
- scheduled for short surgical procedures, which require I-gel insertion for anesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insertion ease |
1 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic monitoring |
15 minutes |
|
|
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 4 |
|
Date of First Enrollment (India)
|
24/01/2024 |
| 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 Yet Recruiting |
| 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
|
For short surgical procedures, insertion of I-gel requires sufficient depth of anesthesia to achieve adequate jaw relaxation and to prevent untoward effects like coughing, gagging, laryngospasm etc. In this study, we will be comparing induction with propofol - fentanyl vs propofol - dexmedetomidine for ease of I-gel insertion in short surgical procedures. |