Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia

NCT07067944 | Completed

• 1 other identifier: 36264MS146/4/23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effects of prophylactic ephedrine and nor-epinephrine infusion on maternal hemodynamics and neonatal outcomes following spinal anesthesia in cesarean deliveries.

Conditions

Perioperative Infusion; Ephedrine; Noradrenaline; Cesarean Delivery; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Maternal systolic blood pressure

  Maternal systolic blood pressure was recorded 10 minutes after induction of spinal anesthesia.

  10 minutes after induction of spinal anesthesia

Secondary Outcomes (4)

• Heart rate

  Intraoperatively

• Number of needed rescue boluses of vasopressors

  After induction of spinal anesthesia (Up to 2 hours)

• Incidence of adverse events

  2 hours after induction of spinal anesthesia

• APGAR score

  5 minutes after delivery

Study Arms (2)

Group A

EXPERIMENTAL

The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min.

Drug: Ephedrine

Group B

EXPERIMENTAL

The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute.

Drug: Noradrenaline

Interventions

Ephedrine DRUG

The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min.

Group A

Noradrenaline DRUG

The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute.

Group B

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Women undergoing cesarean delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 21 years.
• American Society of Anesthesiologists Physical Status II and III.
• Full-term singleton pregnant women scheduled for elective cesarean section under spinal anesthesia.

You may not qualify if:

• Morbid obesity \[body mass index (BMI)\>40\].
• Diabetes Mellitus.
• Severe cardiovascular disease.
• Hypertensive disorders of pregnancy.
• Chronic kidney disease.
• Non-assuring fetal status.
• Peripartum bleeding.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Ephedrine; Norepinephrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)