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To determine if the sedative effect of spinal anaesthesia is increased by intravenous midazolam, a drug commonly used for sedation for spinal anesthesia in patients undergoing lower limb surgeries.

To compare the sedative effect of subarachnoid block with and without intravenous midazolam using BIS monitoring in patients undergoing lower limb surgeries-A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038119
Enrollment
60
Registered
2021-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Intravenous saline: After giving SAB with 2 mL (10 mg) of 0.5% hyperbaric bupivacaine and 0.5 mL (25 �¼g) fentanyl with a 27 g spinal needle or CSE set 18/27, intravenous saline will

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age 20-60 years, either sex, American Society of Anesthesiologists (ASA) physical status I and II undergoing surgery (min duration of 90min) under SAB or combined spinal epidural anesthesia (CSEA) will be enrolled for the study.

Exclusion criteria

Exclusion criteria: Patients with any known allergy to study drugs, contraindication for central neuraxial block, obesity (body mass index, [BMI] >35 kg/m2), neurological or psychiatric disease on concurrent medication and refusal will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To compare mean BIS score after Sub arachnoid block with bupivacaine (H) +fentanyl with and without intravenous midazolamTimepoint: BIS score will be assessed every 15 minutes up to 90 minutes

Secondary

MeasureTime frame
To compare 1) haemodynamic parameters in both groups Timepoint: BIS will be recorded every 15 min during the study by a blinded research assistant. Other monitoring include electrocardiography, heart rate, automated blood pressure, pulse oximetry and respiratory rate at every 15min.Snoring will also be noted.

Countries

India

Contacts

Public ContactDr Ummul Fabeena Mangaladan

AIIMS, New Delhi

jyotsna_punj@yahoo.com9810191116

Outcome results

None listed

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