A study to compare fentanyl and dexmedetomidine with ropivacaine for spinal anaesthesia in patients undergoing lower limb surgery

A COMPARATIVE STUDY OF FENTANYL VS. DEXMEDETOMIDINE AS AN ADJUVANT TO 0.75% ROPIVACAINE IN SPINAL ANAESTHESIA FOR LOWER LIMB SURGERIES - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107240

Enrollment

Registered

2026-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ropivacaine with Fentanyl: Group F will receive 0.75 percent hyperbaric ropivacaine 3 ml with fentanyl 25 microgram intrathecally at L3 L4 interspace using 25 gauge Quincke needle Contr

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (aged 18-45 years) undergoing elective lower limb surgeries under Spinal Anaesthesia ASA (American Society of Anesthesiologists) physical status I / II / III No history of allergies to local anaesthetics or the adjuvants used

Exclusion criteria

Exclusion criteria: Patients unwilling to give consent Contraindications to spinal anaesthesia (e.g., coagulopathy, local infection) Allergy to study drugs Severe systemic disease (ASA IV or higher) Pregnancy and Lactation

Design outcomes

Primary

Measure	Time frame
Onset of sensory block,Onset of motor block,Duration of sensory block and duration of motor blockTimepoint: Intraoperative period upto completion of surgery or 180 minutes , whichever is earlier	—

Secondary

Measure	Time frame
Duration of postoperative analgesia (time to first rescue analgesia)Timepoint: Postoperative period up to 12 hours;Postoperative pain score using visual analogue scaleTimepoint: 0 hours, 2 hours, 4 hours, 6 hours , 8 hours , 10 hours and 12 hours postoperatively;Incidence of adverse effects (nausea, vomiting, pruritus, etc if any)Timepoint: Intraoperative and postoperative period up to 12 hours;Hemodynamic parameters (heart rate, blood pressure, mean arterial pressure)Timepoint: intraoperative period upto completion of surgery or 180 minutes, whichever is earlier;Hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, oxygen saturation)Timepoint: 0 hours, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours - Post operatively	—

Measure

Time frame

Duration of postoperative analgesia (time to first rescue analgesia)Timepoint: Postoperative period up to 12 hours;Postoperative pain score using visual analogue scaleTimepoint: 0 hours, 2 hours, 4 hours, 6 hours , 8 hours , 10 hours and 12 hours postoperatively;Incidence of adverse effects (nausea, vomiting, pruritus, etc if any)Timepoint: Intraoperative and postoperative period up to 12 hours;Hemodynamic parameters (heart rate, blood pressure, mean arterial pressure)Timepoint: intraoperative period upto completion of surgery or 180 minutes, whichever is earlier;Hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, oxygen saturation)Timepoint: 0 hours, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours - Post operatively

—

Countries

India

Contacts

Public ContactVivek Tyagi

National Capital Region Institute of Medical Sciences

drvishalaggarwal7@gmail.com8700220013

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026