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

B.P. Koirala Institute of Health Sciences

Status and phase: Completed; Phase 4

Conditions: Hypotension After Spinal Anesthesia; Hypotension During Cesarean Delivery

Treatments: Drug: Ephedrine; Drug: Normal Saline (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06668337

IRC/1598/019

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 3 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline (Placebo)

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

Experimental group

Description:

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.

Treatment:

Drug: Ephedrine

Drug: Ephedrine

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

Experimental group

Description:

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.

Treatment:

Drug: Ephedrine

Drug: Ephedrine