| CTRI Number |
CTRI/2025/09/094583 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of morphine and dexmedetomidine in spinal anesthesia for patients undergoing infraumbilical surgeries |
|
Scientific Title of Study
|
Comparative evaluation of intrathecal morphine versus dexmedetomidine in patients undergoing infraumbilical surgeries under spinal anesthesia |
| 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 Keerthana N D |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesia,Banglore medical college and research institute Fort,krishna rajendra road,kalasipalya,Bengaluru, karnataka
Department of anaesthesia, Banglore ,medical college and research institute, Fort,krishna rajendra road, kalasipalya, Bengaluru, karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9844716647 |
| Fax |
|
| Email |
ndkeerthana25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhumala H R |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesia, Banglore medical college and research institute ,fort,krishna rajendra road,kalasipalya,Bengaluru, karnataka
Department of anaesthesia , Banglore medical college and research institute,fort ,krishna rajendra road, kalasipalya, Bengaluru, karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9886786768 |
| Fax |
|
| Email |
drmadhumala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerthana N D |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesia, banglore medical college and research institute,Fort,krishna rajendra road,kalasipalya,Bengaluru, karnataka
Department of anaesthesia,Banglore medical college and research institute, fort ,krishna rajendra road, kalasipalya, Bengaluru, karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9844716647 |
| Fax |
|
| Email |
ndkeerthana25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Keerthana N D |
| Address |
Fort,krishna rajendra road, kalasipalya,Bengaluru,karnataka 560002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Keerthana N D |
Bangalore medical college |
Department of anaesthesia, Banglore medical college and research institute, fort, krishna rajendra road, kalsipalya, bengaluru , karnataka 560002
Bangalore
KARNATAKA |
9844716647
ndkeerthana25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe bangalore medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N813||Complete uterovaginal prolapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
5mcg,intrathecal,18 months |
| Comparator Agent |
Morphine |
0.25mg,Intrathecal,18months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to provide informed written consent
2)ASA physical status grade land ll
3)Patient scheduled to undergo elective infraumbilical surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1)Patient allergic to local anesthesia
2)Patient having any Absolute contraindication for spinal anesthesia
3)Acute or chronic respiratory disease
4)Cognitive or psychiatric disturbances
5)Hypertension or other cardiovascular abnormalities
6)Patient with heart block
7)Patient on beta blockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic efficacy in terms of duration of analgesia of adjuvant dexmedetomidine and morphine in spinal anesthesia |
18months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare characteristics of spinal block |
18months |
| To compare perioperative hemodynamic parameters |
18months |
| To compare any adverse effects if any |
18months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2025 |
| 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="1"
Months="6"
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
|
This study is a randomized, double blind, parallel group, comparing the analgesic efficacy of Intrathecal morphine 0.25mg and dexmedetomidine 5mcg in 70 patients for 1.5 years posted for infraumbilical surgeries under spinal anesthesia. |