| CTRI Number |
CTRI/2025/10/096036 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing epidural and intravenous dexmedetomidine for pain relief after lower abdominal surgery |
|
Scientific Title of Study
|
Comparative evaluation of epidural and intravenous dexmedetomidine as adjuvants for prolonging post operative analgesia in adults undergoing infraumbilical surgery under combined spinal epidural anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urmi Ganguly |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7328012885 |
| Fax |
|
| Email |
urmi.ganguly505@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amandeep Jaswal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9582142904 |
| Fax |
|
| Email |
amandeep.jaswal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Urmi Ganguly |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7328012885 |
| Fax |
|
| Email |
urmi.ganguly505@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 |
| 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 |
| Urmi Ganguly |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
7328012885
urmi.ganguly505@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vmmc and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural dexmedetomidine |
Patients in the epidural dexmedetomidine group (intervention group) will receive dexmedetomidine 0.5 µg/kg diluted to 10 mL with normal saline, administered via the epidural route as a single dose along with 5 mL of 0.25% bupivacaine. The solution will be infused epidurally over a period of 30 minutes. Patients will be monitored for 24 hours postoperatively. |
| Comparator Agent |
Intravenous dexmedetomidine |
Patients in the intravenous dexmedetomidine group (comparator group) will receive dexmedetomidine 0.5 µg/kg diluted in 100 mL of normal saline, administered intravenously as a single infusion over 30 minutes, along with 5 mL of 0.25% bupivacaine given epidurally. Patients will also be monitored for 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18 and 65 years, belonging to American Society of Anesthesiologists (ASA) physical status I or II, scheduled to undergo elective infraumbilical surgery under combined spinal epidural anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity or allergy to local anaesthetics or dexmedetomidine.
2. Patients with baseline bradycardia (heart rate less than 50 bpm) or baseline systolic BP less than 90 mmHg.
3. Patients on beta-blockers or alpha-2 agonists.
4. Patients with any contraindications to regional anaesthesia.
5. Patients with a history of chronic opioid use or long-term analgesic therapy.
6. Patients with psychiatric illness or cognitive impairment affecting consent or pain assessment. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia by observing the time of request for the first rescue analgesic dose. |
The primary outcome (duration of postoperative analgesia) will be assessed at predefined intervals — 1, 2, 4, 6, 8, 12, 18, and 24 hours after administration of the study drug, and additionally at the time of first rescue analgesic request. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative sedation score(Modified Ramsay Sedation Score, MRSS) |
postoperatively at 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour |
| Hemodynamic parameters( heart rate, blood pressure,SpO2). |
baseline vitals after wheeling in other. administration of drug ( time zero), 15 minutes, 30 minutes, 30 minutes, 45 minutes, 1st hour, 1.5 hour , 2nd hour, 4th hour, 8th hour and 24th hour |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2025 |
| 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 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 prospective, randomized, comparative study will assess the effect of dexmedetomidine when given by two routes—epidural or intravenous—as an adjuvant to bupivacaine in adults undergoing infraumbilical surgery under combined spinal epidural anaesthesia. Ninety patients aged 18–65 years (ASA I–II) will be included. The primary outcome is the duration of postoperative analgesia, measured by time to first rescue analgesic. Secondary outcomes include sedation using Modified Ramsay Sedation Score and perioperative hemodynamic changes, assessed over 24 hours. |