| CTRI Number |
CTRI/2024/02/062663 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of analgesic effect of perioperative Dexmedetomidine infusion in patients undergoing Major Neurosurgical procedures |
|
Scientific Title of Study
|
A randomized single-blinded placebo control study of perioperative Dexmedetomidine infusion on
24 hour morphine consumption by patient controlled analgesia(PCA) in patients undergoing major
neurosurgical 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 |
Bharat Krishna |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College |
| Address |
Final Year Postgraduate, Department of Anesthesiology, Second Floor, Saveetha Medical College, Saveetha Nagar, Thandalam
Chennai
TAMIL NADU
602105
India |
| Phone |
9500265345 |
| Fax |
|
| Email |
bharatvmch2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunasekaran |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Anesthesiology, Second Floor, Saveetha Medical College, Saveetha Nagar, Thandalam
Chennai
TAMIL NADU
602105
India |
| Phone |
9566137571 |
| Fax |
|
| Email |
swathisekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharat Krishna |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College |
| Address |
Final Year Postgraduate, Department of Anesthesiology, Second Floor, Saveetha Medical College, Saveetha Nagar, Thandalam
Chennai
TAMIL NADU
602105
India |
| Phone |
9500265345 |
| Fax |
|
| Email |
bharatvmch2015@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College |
| Address |
Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai,
Tamil Nadu 602105 |
| Type of Sponsor |
Private 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 Bharat Krishna |
Saveetha Medical College |
Department of Anesthesiology, Second floor, Saveetha Medical College, Saveetha Nagar,
Thandalam, Chennai
Bengaluru, NH 48,
Chennai, Tamil Nadu
602105
Chennai
TAMIL NADU |
9500265345
bharatvmch2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D33||Benign neoplasm of brain and otherparts of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Intravenous infusion at rate of 0.5mcg per kg per hour during the entire course of surgical procedure |
| Comparator Agent |
Normal Saline |
Calculated as for Dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS 3
Elective Neurosurgical procedures |
|
| ExclusionCriteria |
| Details |
Cardiac disorders,
Impaired renal, liver and pulmonary functions
Intellectual disability
Long term use of ACE inhibitors, Beta blockers, Sedatives,
Psychiatric medications
Emergency cases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 24hr cumulative morphine consumption |
1hr, 2hr, 4hr, 6hr, 8hr, 12hr and 24 hr postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of First analgesic request |
24 hours postoperative period |
| Post operative pain assessment using Numerical Rating Scale |
1, 2,4,6,8,12,24 hrs post operative period |
| Incidence of nausea, Vomiting |
24 hours postoperative period |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Objective of the research project: To assess the post-operative opioid sparring effect of perioperative Dexmedetomidine infusion in patients undergoing neurosurgical procedures with post-operative Morphine consumption. The primary objective is the comparison of cumulative morphine consumption in 24hrs (PCA and initial titration) Secondary objectives include comparing the time to first request for post-operative analgesia, assessment and comparison of post-operative pain with Numerical rating scale |