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

Active, not recruiting

• Conditions: Cesarean Section Complications

• Registration Number: NCT07049705
• Lead Sponsor: Superior University

Brief Summary

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

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.

Study Timeline

• Study Start: 2025-03-17
• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-09-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 289

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
structured questionnaire	12 Months	1. Section A: Demographic and Baseline Information; Age, weight, height, gestational age, parity, medical history, medications.; 2. 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.; 3. Section C: Intraoperative Hemodynamic Events; Occurrence of bradycardia (HR \< 60 bpm), lowest HR, time to bradycardia, associated hypotension, interventions used, maternal symptoms.; 4. 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).

Trial Locations

Locations (1)

Maqsood Medical complex; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan