Hypotension After Spinal Anesthesia, Hypotension During Cesarean Delivery
Conditions
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.
Interventions
DRUGNormal Saline (Placebo)
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.
DRUGEphedrine
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.
Sponsors
B.P. Koirala Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Nepal
Outcome results
None listed