Manually Controlled Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section: A Double-blinded Randomized Controlled Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to compare norepinephrine and ephedrine in maintaining blood pressure during spinal anaesthesia for elective cesarean delivery. The main questions it aims to answer are: * Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on neonatal outcome ? * Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on maternal hemodynamics? Participants will receive either phenylephrine or norepinephrine infusion, at the time of performing spinal anesthesia, the infusion rate will be adjusted manually depending on maternal arterial pressure.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Full-term, singleton, pregnant women, nonlaboring.

• Scheduled for elective cesarean delivery under spinal anesthesia,

• American Society of Anesthesiologists physical status : 1 or 2

• Baseline systolic BP between 90 and 140 mm Hg.

Locations
Other Locations
Morocco
University hospital Hassan II
RECRUITING
Fes
University hospital Hassan II
NOT_YET_RECRUITING
Fes
Contact Information
Primary
Mohamed Adnane Berdai, MD-PhD
adnane.berdai@yahoo.fr
+212655260752
Time Frame
Start Date: 2025-01-29
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 140
Treatments
Active_comparator: Phenylephrine
The infusion will have a concentration of Phenylephrine of 25 μg/mL and will be initiated at a rate of 96 mL/hour (1.6 mL/minute), that correspond to a phenylephrine rate infusion of 40 μg/min, then the infusion rate will be manually adjusted within the range 0-144 mL/h : PHE (0-60 μg/min).
Experimental: Norepinephrine
The infusion will have a concentration of Norepinephrine of 4 μg/mL and will be initiated at a rate of 96 mL/hour (1.6 mL/minute), that correspond to norepinephrine rate infusion of 6.4 μg/min, then the infusion rate will be manually adjusted within the range 0-144 mL/h : Norepinephrine (0-9.6 µg/min).
Related Therapeutic Areas
Sponsors
Leads: Hassan II University

This content was sourced from clinicaltrials.gov