| CTRI Number |
CTRI/2025/12/099726 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of intravenous dexmedetomidine in prolonging spinal anaesthesia in infraumblical surgeries |
|
Scientific Title of Study
|
To study the efficacy of intravenous dexmedetomidine in prolonging spinal anaesthesia in infraumblical surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drkrishnappreya |
| Designation |
post graduate |
| Affiliation |
vinayaka mission medical college and hospital ,salem |
| Address |
Room no 15,Anaesthesia department,vinayaka mission medical college and hospital ,salem 636308
Salem
TAMIL NADU
636016
India |
| Phone |
09487873738 |
| Fax |
|
| Email |
nimmu1335@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drkrishnappreya |
| Designation |
post graduate |
| Affiliation |
vinayaka mission medical college and hospital ,salem |
| Address |
Room no 15,Anaesthesia department,vinayaka mission medical college and hospital ,salem 636308
TAMIL NADU
636016
India |
| Phone |
09487873738 |
| Fax |
|
| Email |
nimmu1335@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drkrishnappreya |
| Designation |
post graduate |
| Affiliation |
vinayaka mission medical college and hospital ,salem |
| Address |
Room no 15,anaesthesia department,vinayaka mission medical college and hospital salem 636018
TAMIL NADU
636016
India |
| Phone |
09487873738 |
| Fax |
|
| Email |
nimmu1335@gmail.com |
|
|
Source of Monetary or Material Support
|
| vinayaka mission medical college and hospital salem 636018 |
|
|
Primary Sponsor
|
| Name |
vinayaka mission medical college and hospital salem |
| Address |
chinnaseeragapadi,salem |
| 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 |
| Drkrishnappreya |
Vinayaka Mission medical college and hospital salem |
Room no 15, anaesthesia department, vinayaka mission medical college,salem 636308
Salem
TAMIL NADU |
09487873738
nimmu1335@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee vinayaka mission kirupanandha variyar medical college and hospitals salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To study the efficacy of intravenous dexmedetomidine in prolonging spinal anaesthesia in infraumblical surgeries |
Patient given 3ml 0.5% BUPIVACAINE with 0.5mcg/kg dexmeditomidine in 100ml NS over 10 minutes and compared with other group with normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II.
Age between 18-60 years
All infra umbilical elective surgeries
|
|
| ExclusionCriteria |
| Details |
• Patient refusal.
• Age less than 18 and more than 60 years .
• ASA grade 3&4.
• Severe hepatic or renal failure
• Patient with known allergy to LA drugs
• Patients suffering from IHD, angina , arrhythmias, heart block, Previous MI.
• Patients with contraindication to spinal anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of intravenous dexmedetomidine on the duration of sensory and motor blockade. |
From zero minutes to three hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic profile and the level of sedation following dexmedetomidine |
from zero minutes to three hours of surgery |
|
|
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 1 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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 is the Randomized clinical study to look after the efficacy of intravenous dexmedetomidine in prolonging spinal anaesthesia in infraumblical surgeries like hernia and all other |