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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maqsood Medical complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

structured questionnaire

Time frame: 12 Months
- Section A: Demographic and Baseline Information
Age, weight, height, gestational age, parity, medical history, medications.
- Section B: Anesthetic and Surgical Details
Indication for cesarean (elective/emergency), baseline heart rate and BP, type/dose of anesthetic, sensory block level, fluid administration, blood loss.
- Section C: Intraoperative Hemodynamic Events
Occurrence of bradycardia (HR < 60 bpm), lowest HR, time to bradycardia, associated hypotension, interventions used, maternal symptoms.
- Section D: Neonatal Outcomes
Apgar scores at 1 and 5 minutes, NICU admission and reasons.

Scoring:

There is no numerical scoring system described. Instead:

Responses are mostly categorical or numerical entries (e.g., Yes/No, HR value, BP value, Apgar score).

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 3, 2025
Registry last updated: Jul 3, 2025

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.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting