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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06748794
Enrollment
64
Registered
2024-12-27
Start date
2024-02-28
Completion date
2025-03-01
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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.

Interventions

DIAGNOSTIC_TESTgroup 1

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.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative analgesia12 MonthsTime from intrathecal drug administration to the first request for additional analgesia by the patient.
Quality of sensory and motor block12 MonthsOnset, level, and duration of sensory block, Onset and duration of motor block, Maximum sensory block level achieved.
Hemodynamic stability12 monthsIncidence and severity of hypotension, bradycardia, or other hemodynamic changes during the perioperative period.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026