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NCT Number: NCT06748794

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Nowshera

Nowshera, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)"

Treatment and study plan

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.

Primary outcomes

  1. Duration of postoperative analgesia

    Time frame: 12 Months

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

  2. Quality of sensory and motor block

    Time frame: 12 Months

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

  3. Hemodynamic stability

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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