| CTRI Number |
CTRI/2024/04/065270 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
obsevational study |
| Study Design |
Other |
|
Public Title of Study
|
To determine the effectiveness of Demedetomidine given intraoperatively in decreasing analgesic requirement in postoperative period and enhancing recovery |
|
Scientific Title of Study
|
The Efficacy Of Intraoperative Dexmedetomidine On Postoperative Analgesia and Recovery In Patients Undergoing Gynaecological 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 |
NARLA GARY RENIL |
| Designation |
POST GRADUATE |
| Affiliation |
Kasturba medical college,Mangalore |
| Address |
Postgraduate
Department Of Anaesthesiology
Light House Hill Road
Kasturba Medical college Mangalore
Dakshina kannada
Karnataka
575001
INDIA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9493094455 |
| Fax |
|
| Email |
garyrenil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILA S KAMATH |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Professor
Department Of Anaesthesiology
Light House Hill Road
Kasturba Medical College
Mangalore
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9844090231 |
| Fax |
|
| Email |
shailakamath@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAILA S KAMATH |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Professor
Department Of Anaesthesiology
Light House Hill Road
Kasturba Medical College Mangalore
Dakshina kannada
Karnataka
575001
INDIA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9844090231 |
| Fax |
|
| Email |
shailakamath@ymail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, kasturba medical college, Light house Hill Road
Mangalore
Dakshina Kannada
575001 |
|
|
Primary Sponsor
|
| Name |
Dr Shaila S Kamath |
| Address |
Department Of Anaesthesiolog
Light house hill Road
Kasturba Medical College Mangalore
Dakshina Kannada
Karnataka
575001
India |
| Type of Sponsor |
Other [Deemed to be university] |
|
|
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 Gary Renil |
Kasturba medical college, Mangalore hospitals |
Department of Anaesthesiology Kasturba Medical college
Light house hill road
mangalore
Dakshana kannada
mangalore
karnataka
karnataka
575001
Dakshina Kannada
KARNATAKA |
9493094455
garyrenil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1)Women aged 35-65 years
2)patients with ASA 1 & 2
3)patients undergoing elective gynecological surgeries under general anesthesia.
4)surgical time within 3 hours
|
|
| ExclusionCriteria |
| Details |
1)Patients not willing to participate in the study
2)ASA 3 and above
3)Emergency gynecological surgeries
4) Patients with severe pulmonary, hepatic, cardiac, or renal disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Postoperative analgesic requirement
2) Recovery time |
surgical time within 3hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Hemodynamic variables
2) Intraoperative blood loss |
Surgical time within 3 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Intravenous infusion of Dexmedetomidine is routinely is used in anesthesia for achieving deeper plane of anesthesia. Numerous studies regarding injection Dexmedetomidine have been conducted either in the form of intravenous infusion or intravenous injection but this study will lay its focus on combing both intravenous infusion and intravenous bolus for postoperative analgesia and recovery. |