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.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/11/038119
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To compare <br/ ><br>1) haemodynamic parameters in both groups <br/ ><br>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.