A study comparing epidural and intravenous dexmedetomidine for pain relief after lower abdominal surgery

Comparative evaluation of epidural and intravenous dexmedetomidine as adjuvants for prolonging post operative analgesia in adults undergoing infraumbilical surgery under combined spinal epidural anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096036

Enrollment

Registered

2025-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified

Interventions

Intervention1: 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 vi

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To compare the duration of postoperative analgesia by observing the time of request for the first rescue analgesic dose.Timepoint: 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

Measure	Time frame
Postoperative sedation score(Modified Ramsay Sedation Score, MRSS)Timepoint: postoperatively at 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour;Hemodynamic parameters( heart rate, blood pressure,SpO2).Timepoint: 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	—

Measure

Time frame

Postoperative sedation score(Modified Ramsay Sedation Score, MRSS)Timepoint: postoperatively at 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour;Hemodynamic parameters( heart rate, blood pressure,SpO2).Timepoint: 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

—

Countries

India

Contacts

Public ContactUrmi Ganguly

Vardhman Mahavir Medical College and Safdarjung Hospital

amandeep.jaswal05@gmail.com9582142904

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026