| CTRI Number |
CTRI/2025/09/095366 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Doses of Dexmedetomidine with Ropivacaine for Pain Relief after Lower Abdominal Surgery |
|
Scientific Title of Study
|
A Randomized Comparative Study of Analgesic Effect of Addition of Two Different Doses of Dexmedetomidine as an Adjuvant to Intrathecal Hyperbaric Ropivacaine for Infraumbilical Surgery |
| 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 Sakshi Singh |
| Designation |
PG Resident |
| Affiliation |
Jhalawar Medical College |
| Address |
Department of Anaesthesiology Jhalawar Medical College Associated Hospitals Jhalawar Rajasthan.
Jhalawar
RAJASTHAN
326001
India |
| Phone |
7460819259 |
| Fax |
|
| Email |
dr.sakshi29122016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Singh |
| Designation |
PG Resident |
| Affiliation |
Jhalawar Medical College |
| Address |
Jhalawar Medical College and Associated Hospitals Jhalawar Rajasthan
Department of Anaesthesia, Jhalawar Medical College and hospitals, Jhalawar, Rajasthan
Jhalawar
RAJASTHAN
326001
India |
| Phone |
07460819259 |
| Fax |
|
| Email |
dr.sakshi29122016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratibha Rathore |
| Designation |
Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
SMS Medical College Jaipur Rajasthan India
SMS Medical College, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302015
India |
| Phone |
09414446473 |
| Fax |
|
| Email |
pratibha.rathore3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jhalawar Medical College & Associated Hospitals, Jhalawar, Rajasthan, India – provided infrastructural support for the conduct of the study. No external monetary funding
|
|
|
Primary Sponsor
|
| Name |
Jhalawar medical college and hospital Jhalawar Rajasthan India |
| Address |
Jhalawar Medical College and Hospital Jhalawar Rajasthan India |
| Type of Sponsor |
Government 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 Sakshi Singh |
Jhalawar Medical College & Associated Hospitals |
Department of Anaesthesiology, Jhalawar Medical College & Associated Hospitals, Jhalawar, Rajasthan.
Jhalawar
RAJASTHAN |
07460819259
dr.sakshi29122016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jhalawar Medical College and Associated Hospitals Jhalawar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine 2 mcg with 0.75% hyperbaric ropivacaine |
3.0 ml of 0.75% hyperbaric ropivacaine + 2 mcg dexmedetomidine (diluted in 0.5 ml saline), total volume 3.5 ml intrathecal.
otal duration of intervention: Effect monitored intraoperatively and up to 24 hours postoperatively. |
| Intervention |
Dexmedetomidine 4 mcg with 0.75% hyperbaric ropivacaine |
3.0 ml of 0.75% hyperbaric ropivacaine + 4 mcg dexmedetomidine (diluted in 0.5 ml saline), total volume 3.5 ml intrathecal.
otal duration of intervention: Effect monitored intraoperatively and up to 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I & II
Weight between 45–70 kg
Patients scheduled for elective infraumbilical surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal
Sepsis or infection at puncture site
Severe systemic illness (renal, hepatic, cardiac, respiratory)
Raised intracranial tension
Coagulopathy
Allergy to study drugs
Failed spinal block |
|
|
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 |
Time to first rescue analgesia.
Total number of rescue analgesic doses in first 24 hours. |
Assessed at regular intervals up to 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Onset of sensory block.
2. Duration of sensory block.
3. Onset and duration of motor block.
4. Hemodynamic variables(HR, BP, Spo2)
5. Sedation score
6. VAS pain score
7. Outcome |
1. From injection to T10 level.
2. Till regression to S1 dermatome.
3. Assessed intraoperatively and postoperatively.
4. Baseline, every 5min intraop, then hourly for 6 hours.
5. Intraoperative and postoperative(upto 24hrs)
6. 0,2,4,6,12,24 hrs postoperatively.
7. Throughout intraoperative and 24hrs postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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 Yet Recruiting |
| 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
|
A randomized, double blind, parallel group clinical trial designed to compare the analgesic efficacy of two different doses of dexmedetomidine (2 mcg vs 4 mcg) as an adjuvant to intrathecal hyperbaric ropivacaine in patients undergoing infraumbilical surgeries. The primary outcomes are time to first rescue analgesia and total number of rescue analgesics required in 24 hours. Secondary outcomes include onset and duration of sensory and motor block, hemodynamic changes, sedation score, VAS score, and adverse effects. A total of 64 patients will be enrolled and randomized into two groups of 32 each. The study will be conducted at Jhalawar Medical College and Associated Hospitals, Rajasthan, after approval by the Institutional Ethics Committee. |