Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for C-section

Active, not recruiting

• Conditions: Cesarean Section Complications

• Registration Number: NCT06748794
• Lead Sponsor: Superior University

Brief Summary

This study evaluates the effects of intrathecal midazolam (1 mg) combined with hyperbaric bupivacaine 0.5% (15 mg) for spinal anesthesia in cesarean section patients.

Detailed Description

The addition of midazolam, a benzodiazepine with analgesic and anxiolytic properties to bupivacaine is hypothesized to enhance the quality of anesthesia and postoperative pain relief without significant side effects. A comparative analysis was conducted to assess sensory and motor block characteristics, postoperative analgesia duration, maternal hemodynamic stability, and neonatal outcomes.

Study Timeline

• Study Start: 2024-02-28
• Primary Completion: 2024-07-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Female patients presented for elective cesarean section.
• All ASA I & II patients .
• Age between 18 to 35 years.

Exclusion Criteria

• Contraindication to spinal anesthesia.
• Patient not willing or previous bad experience with it.
• All ASA III & IV class was excluded from the study.
• Patients with documented bleeding disorders i.e. low platelet count, deranged PT/APTT/INR, DIC etc.
• Hypertensive patients
• Patients with Diabetes mellitus.
• Obese patients BMI >30.
• PIH (pre- eclampsia and eclapmsia)"

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of postoperative analgesia	12 Months	Time from intrathecal drug administration to the first request for additional analgesia by the patient.
Quality of sensory and motor block	12 Months	Onset, level, and duration of sensory block, Onset and duration of motor block, Maximum sensory block level achieved.
Hemodynamic stability	12 months	Incidence and severity of hypotension, bradycardia, or other hemodynamic changes during the perioperative period.

Trial Locations

Locations (1)

Nowshera; 🇵🇰 Nowshera, Khyber Pakhtunkhwa, Pakistan