Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section (NCT06668337) | Clinical Trial Compass
CompletedPhase 4
Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section
Nepal120 participantsStarted 2020-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.
Timeframe: 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