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

NCT07049705 | Active Not Recruiting DMC

• 1 other identifier: MSAHSW/Batch-Fall23/916
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• structured questionnaire

  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).

  12 Months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Maqsood Medical complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: March 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)