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

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.

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Key information

Conditions

Hypotension After Spinal Anesthesia Hypotension During Cesarean Delivery

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

B.P. koirala Institute of Health Sciences

Dharān, Nepal

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

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.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing the Effectiveness of Different Doses of Ephedrine Infusion in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Oct 31, 2024
Registry last updated: Oct 31, 2024

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.

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