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

NCT06668337 | Completed Phase 4 DMC

• 1 other identifier: IRC/1598/019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension After Spinal Anesthesia; Hypotension During Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.

  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.

  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

Study Arms (3)

Group A who received normal saline immediately after the administration of the

PLACEBO COMPARATOR

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

Drug: Normal Saline (Placebo)

Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block

EXPERIMENTAL

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.

Drug: Ephedrine

Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block

EXPERIMENTAL

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.

Drug: Ephedrine

Interventions

Normal Saline (Placebo) DRUG

Participants in the control group receive a continuous intravenous infusion of normal saline, which serves as an inert placebo with no pharmacological effect. This intervention mimics the administration of the active treatments, allowing for direct comparison with the ephedrine groups to assess the effectiveness of the drug in preventing maternal hypotension during spinal anesthesia.

Group A who received normal saline immediately after the administration of the

Ephedrine DRUG

The interventions in this study include a control group receiving normal saline, which serves as an inert placebo to assess the effectiveness of the active treatments. Participants in Group B receive an ephedrine infusion at 1.25 mg/min, while those in Group C receive a higher dosage of 1.5 mg/min. This design allows for direct comparison of the two dosages of ephedrine against the control, enabling evaluation of their effectiveness in preventing maternal hypotension following spinal anesthesia during cesarean sections.

Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is open to individuals who self-identify as female. Eligible participants must be of reproductive age and capable of providing informed consent. The focus on females is due to the study's aim to investigate maternal hypotension during spinal anesthesia specifically in the context of cesarean sections.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B.P. koirala Institute of Health Sciences

Dharān, Nepal

Location

MeSH Terms

Interventions

Saline Solution; Ephedrine

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: February 15, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

NE (1)