Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section

Phase 4

Completed

• Conditions: Hypotension After Spinal Anesthesia; Hypotension During Cesarean Delivery
• Interventions: Drug: Normal Saline (Placebo); Drug: Ephedrine

• Registration Number: NCT06668337
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

This randomized controlled trial aims to compare the effectiveness of different doses of ephedrine infusion in preventing maternal hypotension following spinal anesthesia in parturients undergoing cesarean sections. The study includes 120 participants, aged 18-40 years, with American Society of Anesthesiologists (ASA) physical status II, who are scheduled for elective cesarean delivery. The primary objective is to determine whether low-dose ephedrine infusions at 1.25 mg/min or 1.5 mg/min effectively reduce the incidence of maternal hypotension, with secondary outcomes assessing the need for rescue ephedrine, incidence of side effects (nausea, vomiting, tachycardia), and neonatal Apgar scores. Researchers will compare three groups-saline, 1.25 mg/min ephedrine, and 1.5 mg/min ephedrine-to evaluate their impact on maternal hemodynamic stability.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-08-01
• Study Completion: 2022-02-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Patients undergoing cesarean section
• Self-identified as female
• American Society of Anesthesiologists (ASA) physical status II
• Aged between 18 to 40 years
• Full-term singleton pregnancies planned for cesarean delivery under spinal anesthesia

Exclusion Criteria

• Body mass index (BMI) ≥ 40 kg/m²
• Height less than 145 cm
• Presence of severe neurological or psychiatric conditions
• History of pre-eclampsia
• Severe renal or metabolic disorders
• Contraindications to spinal anesthesia
• Antenatal evidence of fetal anomalies
• Cases with severely compromised fetuses requiring immediate general anesthesia
• Baseline systolic blood pressure (SBP) less than 90 mm Hg
• Pregnancy-induced hypertension
• Refusal to provide written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A who received normal saline immediately after the administration of the	Normal Saline (Placebo)	Participants in this group received normal saline immediately after the administration of the subarachnoid block (spinal anesthesia). This group serves as the control group to compare the effectiveness of ephedrine against no pharmacologic intervention
Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block	Ephedrine	Participants in this group received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block. This dose is intended to prevent maternal hypotension by maintaining blood pressure during spinal anesthesia.
Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block	Ephedrine	Participants in this group received ephedrine at a higher dosage of 1.5 mg/min immediately following the subarachnoid block. This intervention tests whether a slightly higher dose of ephedrine provides better prevention of maternal hypotension without increasing side effects.

Primary Outcome Measures

Name	Time	Method
Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.	Hypotension episodes were monitored and recorded intraoperatively, immediately following the administration of spinal anesthesia until the end of the cesarean section procedure. The time frame for evaluating this outcome was during the surgical procedure	The primary outcome of the study is the incidence of maternal hypotension, defined as a decrease in systolic blood pressure (SBP) by more than 20% from baseline, in patients who received different doses of ephedrine (1.25 mg/min or 1.5 mg/min) or saline infusion following spinal anesthesia for cesarean section.

Trial Locations

Locations (1)

B.P. koirala Institute of Health Sciences; 🇳🇵 Dharan, Nepal