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

NCT ID: NCT06748794

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-28

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Cesarean Section Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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group 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)"
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nowshera

Nowshera, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSAHS/Batch-Spring23/049

Identifier Type: -

Identifier Source: org_study_id