| CTRI Number |
CTRI/2026/04/108801 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effect of a pain-relief medicine given through a vein versus the spine to improve comfort after lower body surgery. |
|
Scientific Title of Study
|
Efficacy of adjuvant effect of intravenous vs intrathecal
dexmedetomidine on 0.5%Hyperbaric levobupivacaine for
postoperative analgesia in patients undergoing lower abdominal and
lower limb surgeries under Subarachnoid block- a prospective double blinded randomised controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sakthivel |
| Designation |
Postgraduate |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute
Kelambakkam
D block,1st floor
2nd year postgraduate
Department of Anaesthesiology
Chennai
TAMIL NADU
603103
India |
| Phone |
9578704142 |
| Fax |
|
| Email |
drpriyanka194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Sakthivel |
| Designation |
Postgraduate |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute
Kelambakkam
D block , 1st floor
Operation Theatre 2
Department of Anaesthesiology
Chennai
TAMIL NADU
603103
India |
| Phone |
9489404818 |
| Fax |
|
| Email |
pugalenthi08@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Sakthivel |
| Designation |
Postgraduate |
| Affiliation |
Chettinad hospital and research institute |
| Address |
Chettinad hospital and research institute
Kelambakkam
D block , 1st floor
Operation Theatre 2
Department of Anaesthesiology
Chennai
TAMIL NADU
603103
India |
| Phone |
9578704142 |
| Fax |
|
| Email |
drpriyanka194@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Dean |
| Address |
Chettinad hospital & research institute
Kelambakkam
Chennai603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrARUNKUMAR |
Chettinad hospital & research institute |
Dblock ,1st floor
Department of Anaesthesiology
Kelambakkam 603103
Chennai
TAMIL NADU |
044 47411000
044 47411011
pugalenthi08@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee for student research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: N433||Hydrocele, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine 0.5microgram/kg in 100l Ns in a subarachnoid block of 0.5% hyperbaric levobupivacaine 3.4ml plus 0.1ml normal saline |
Intravenous route |
| Intervention |
Dexmedetomidine 10microgram with 3.4ml of 0.5% hyperbaric levobupivacaine |
Intrathecal route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients under American society of Anaesthesiologist classification of class I & II
Posted for elective lower abdominal and lower limb surgeries |
|
| ExclusionCriteria |
| Details |
Coagulation abnormalities
Bleeding disorder
Spine deformity
Cardiac /renal disease
Drug allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia between two administration routes |
0 minutes
3 minutes
5 minutes
then every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of motor block
Onset of sensory block
Time taken for 2 point regression
Duration of sensory blockade
Duration of motor blockade
|
0 minutes
3 minutes
5 minutes
then every 15 minutes until 2hrs & every 1 hr post surgery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
03/05/2026 |
| 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 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
|
Analysis of safety profiles and side effects. • Recommendations on optimal dexmedetomidine administration route. |