A study comparing two drugs (Phenylephrine and Mephentermine) to prevent low blood pressure during spinal anesthesia for cesarean delivery

A Randomized Controlled Trial Comparing the Phenylephrine hydrochloride and Mephentermine in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250102064259N1

Enrollment

Registered

2025-01-11

Start date

2019-07-01

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of maternal hypotension associated with spinal anesthesia during cesarean section..

Interventions

Intervention 1: Intervention Group A: Prophylactic infusion of phenylephrine hydrochloride at 50 µg/min, with a bolus dose of 100 µg administered if hypotension occurred. Intervention 2: Intervention

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists (ASA) physical status II Parturients Aged between 18 to 40 years and height >150 cm Full-term singleton pregnancies Scheduled for a cesarean delivery using spinal anesthesia

Exclusion criteria

Exclusion criteria: Body mass index (BMI) = 40 kg/m² Presence of severe neurological or psychiatric conditions History of pre-eclampsia, severe renal or Metabolic disorders, Diabetes mellitus, Coagulopathy, Polyhydramnios, 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 Contraindications to regional block, preoperative hemoglobin less than 10 gm% Pregnancy-induced hypertension and refusal to provide written consent

Design outcomes

Secondary

Measure	Time frame
Neonatal outcomes and adverse effects in mothers, including nausea, vomiting, bradycardia, and neonatal Apgar scores. Timepoint: Neonatal outcomes measured immediately after birth; adverse maternal effects monitored intraoperatively and up to 2 hours postoperatively. Method of measurement: Neonatal Apgar scores assessed by a pediatrician, and maternal side effects recorded using a clinical observation form.	—

Measure

Time frame

Neonatal outcomes and adverse effects in mothers, including nausea, vomiting, bradycardia, and neonatal Apgar scores. Timepoint: Neonatal outcomes measured immediately after birth; adverse maternal effects monitored intraoperatively and up to 2 hours postoperatively. Method of measurement: Neonatal Apgar scores assessed by a pediatrician, and maternal side effects recorded using a clinical observation form.

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Primary

Measure	Time frame
Incidence of maternal hypotension following spinal anesthesia during cesarean section in the phenylephrine and mephentermine groups. Timepoint: Measured at baseline (pre-anesthesia), immediately after spinal anesthesia, and every 2 minutes until delivery, then every 5 minutes thereafter for 30 minutes. Method of measurement: Blood pressure measured using a non-invasive automated sphygmomanometer at specified intervals.	—

Measure

Time frame

Incidence of maternal hypotension following spinal anesthesia during cesarean section in the phenylephrine and mephentermine groups. Timepoint: Measured at baseline (pre-anesthesia), immediately after spinal anesthesia, and every 2 minutes until delivery, then every 5 minutes thereafter for 30 minutes. Method of measurement: Blood pressure measured using a non-invasive automated sphygmomanometer at specified intervals.

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Countries

Nepal

Contacts

Public ContactAmit Yadav

Maharajgunj Medical Campus

amityadav@mmciom.edu.np+977 986-0599113

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026