Factors Influencing Bradycardia During Spinal Anesthesia in Obstetric Patients Undergoing Cesarean Section

NCT ID: NCT07049705

Last Updated: 2025-07-03

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

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-02-28

Brief Summary

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The study titled "Factors Influencing Bradycardia During Spinal Anaesthesia in Obstetric Patients Undergoing Caesarean Section"" aims to investigate the causes and patterns of bradycardia in pregnant women receiving spinal anesthesia during cesarean deliveries. Bradycardia, defined as a heart rate below 60 beats per minute, is a known complication of spinal anesthesia, often resulting from sympathetic blockade and unopposed parasympathetic activity. This condition may lead to hypotension, decreased cardiac output, and compromised fetal oxygenation.

Detailed Description

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The research seeks to enhance the understanding of both patient-specific and procedural risk factors, contributing to improved clinical management, safer anesthesia practices, and better maternal-fetal outcomes. Ethical approval and informed consent protocols are included to ensure participant safety and data confidentiality.

Conditions

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Cesarean Section Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Obstetric patients aged 18-40 years.
* Undergoing elective or emergency cesarean sections under spinal anesthesia.
* Classified as ASA Physical Status I or II (relatively healthy or with mild systemic disease).
* Provided informed consent (either by the patient or legal guardian).

Exclusion Criteria

* Patients with pre-existing cardiac conditions (e.g., arrhythmias, conduction abnormalities).
* Patients taking medications that affect heart rate, such as beta-blockers or calcium channel blockers.
* Patients with contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site).
* Those undergoing combined spinal-epidural or general anesthesia.
* Patients with incomplete medical records or unable to provide informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Maqsood Medical complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSAHSW/Batch-Fall23/916

Identifier Type: -

Identifier Source: org_study_id

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