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

NCT06748794 | Active Not Recruiting DMC

• 1 other identifier: MSAHS/Batch-Spring23/049
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (3)

• Duration of postoperative analgesia

  Time from intrathecal drug administration to the first request for additional analgesia by the patient.

  12 Months

• Quality of sensory and motor block

  Onset, level, and duration of sensory block, Onset and duration of motor block, Maximum sensory block level achieved.

  12 Months

• Hemodynamic stability

  Incidence and severity of hypotension, bradycardia, or other hemodynamic changes during the perioperative period.

  12 months

Interventions

group 1 DIAGNOSTIC_TEST

A comparative analysis was conducted to assess sensory and motor block characteristics, postoperative analgesia duration, maternal hemodynamic stability, and neonatal outcomes. Results demonstrated that intrathecal midazolam significantly prolonged postoperative analgesia and reduced analgesic requirements while maintaining hemodynamic stability and maternal-neonatal safety. This combination provides a potential enhancement to spinal anesthesia techniques, improving maternal comfort and overall perioperative outcomes in obstetric patients.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Caesarean Section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

to check the Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for Caesarean Section

You may qualify if:

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

You may not qualify if:

• 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)"

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Nowshera

Nowshera, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Interventions

Chromosomes, Human, 1-3

Intervention Hierarchy (Ancestors)

Chromosomes, Human; Chromosomes, Mammalian; Chromosomes; Genetic Structures; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: February 28, 2024
• Primary Completion: July 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)