Comparison of Two Medicines (Fentanyl and Magnesium Sulfate) Used in Spinal Anaesthesia for Pain Relief in Lower Body Surgeries

Comparison of Fentanyl and Magnesium Sulfate as Adjuvant in Spinal Anaesthesia in Lower Limb and Abdominal Surgeries. A Double Blinded Randomized Study. - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109046

Enrollment

110

Registered

2026-04-22

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: Comparison of Fentanyl with Bupivacaine and Magnesium Sulfate with Bupivacaine: Patients undergoing lower limb and abdominal surgeries will be divided into 2 groups of 55 each .Group-A(

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA Physical status- 1 and 2 2) All patients placed for lower limb and abdominal surgeries 3)The surgical procedure to be performed under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1) Uncontrolled co-morbidities like Hypertension, Diabetes, Heart Disease and coagulation abnormalities 2) All contra-indications for spinal anaesthesia 3) Known Hypersensitivity to the study drugs. 4) Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Comparison of effect on onset and duration of Sensory and Motor Blocks in both the groups. Perioperative Hemodynamic monitoring- Heart rate, Blood Pressure, Respiratory rate and Spo2 within 24 hours.Timepoint: Comparison of effect on onset and duration of Sensory and Motor blocks in both the groups. Perioperative Hemodynamic monitoring- Heart rate, Blood Pressure, Respiratory rate and Spo2 at 0/2/5/10/15/30/45/60 mins intraoperatively and 0/2/4 hours till rescue analgesia given(every 2 hourly).	—

Measure

Time frame

Comparison of effect on onset and duration of Sensory and Motor Blocks in both the groups. Perioperative Hemodynamic monitoring- Heart rate, Blood Pressure, Respiratory rate and Spo2 within 24 hours.Timepoint: Comparison of effect on onset and duration of Sensory and Motor blocks in both the groups. Perioperative Hemodynamic monitoring- Heart rate, Blood Pressure, Respiratory rate and Spo2 at 0/2/5/10/15/30/45/60 mins intraoperatively and 0/2/4 hours till rescue analgesia given(every 2 hourly).

—

Secondary

Measure	Time frame
Comparison of occurrence of intra operative adverse reactions( Nausea, vomiting, pruritis, bradycardia, Hypotension) in either groups. Time for first rescue analgesia.Timepoint: Intraoperative,Postoperatively-0/2/4 hours till rescue analgesia given (every 2 hourly)	—

Countries

India

Contacts

Public ContactDr Sudhir Sachdev

Mahatma Gandhi Medical College and Hospital

chiefadvisor@mgumst.org9829055666

Outcome results

None listed

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