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WE WANT TO STUDY TO COMPARE EFFICACY OF FENTANYL VERSUS MIDAZOLAM AS AN ADJUVANT TO 0.5% HEAVY BUPIVACAINE IN SUBARACHNOID BLOCK IN LOWER LIMB SURGERIES

STUDY TO COMPARE EFFICACY OF FENTANYL VERSUS MIDAZOLAM AS AN ADJUVANT TO 0.5% HEAVY BUPIVACAINE IN SUBARACHNOID BLOCK IN LOWER LIMB SURGERIES, A PROSPECTIVE RANDOMISED DOUBLE BLIND INTERVENTIONAL STUDY IN DEPARTMENT OF ANAESTHESIA , S.M.S MEDICAL COLLEGE JAIPUR - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109079
Enrollment
40
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: Fentanyl as an adjuvant: Patient received 3ml of 0.5 percentage hyperbaric bupivacaine hydrochloride with 0.5ml (25mcg) fentanyl( preservative free)intrathecally Control Intervention1:

Sponsors

SMS Medical College and Hospital Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing lower limb surgery under spinal Anesthesia 2. Patients who will give informed written consent 3.Belonging to ASA class 1 and class 2

Exclusion criteria

Exclusion criteria: 1. Patients posted emergency surgery. 2. Patients having any significant systemic disorder. 3. Patients having any Drug allergy history. 4. Contraindications for spinal Anesthesia

Design outcomes

Primary

MeasureTime frame
To assess and compare the onset of sensory block,duration of sensory block , onset of motor block , duration of motor block between the two groupsTimepoint: Baseline ,2,5,10,20,30,40,50,60,75,90 minutes after block—

Secondary

MeasureTime frame
To determine change in hemodynamic variables ( HR,SBP,DBP,MBP,SPo2) and side effects with different time intervalTimepoint: Baseline ,2,5,10,20,30,40,50,60,75,90 minutes after block—

Countries

India

Contacts

Public ContactDr Shriphal Meena

SMS Medical College and Hospital Jaipur

Yamanggoyal@gmail.com7526861726

Outcome results

None listed

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