Comparison of phenylephrine versus norepinephrine for maintenance of hemodynamic during cesarean section under spinal anesthesia.

Phase 1

• Conditions: hypotension during caesarean section under spinal anesthesia; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-003182-34-FR
• Lead Sponsor: CHR d'ORLEANS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-30
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

-Pregnancy > 36 weeks of amenorrhea
-Scheduled or semi-urgent (interval between decision and delivery by caesarean section >12hours) caesarean section under spinal anesthesia

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Extreme size (<140cm,> 180cm)
-Weight less than 50kg
- body mass index (BMI) >40 kg/m2
-Cardiovascular disease with use of cardiac medication
-Active neurological disease.
-antihypertensive drug.
-severe pre-eclampsia
-American Society of Anesthesiologists physical status class >3
-Placenta accreta / percreta
-Cesarean section scheduled under general anesthesia.
-Contraindications to spinal anesthesia
-age less than 18 years
-guardianship, curatorship
-Anemia <= 8g / dl
-allergy to any study medication
-simultaneous participation in another study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified