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

December 19, 2024 updated by: Muhammad Naveed Babur, Superior University

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Nowshera, Khyber Pakhtunkhwa, Pakistan
        • Nowshera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative analgesia
Time Frame: 12 Months
Time from intrathecal drug administration to the first request for additional analgesia by the patient.
12 Months
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.
12 Months
Hemodynamic stability
Time Frame: 12 months
Incidence and severity of hypotension, bradycardia, or other hemodynamic changes during the perioperative period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MSAHS/Batch-Spring23/049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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