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Manging Post Spinal Hypotension During Elective Cesarean Section

NCT03704909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2019-03-13

No results posted yet for this study

Summary

Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%. This can result in significant morbidity for both the mother and fetus.The purpose of this study is to determine if epinephrine is as effective and safe compared to ephedrine for maintaining arterial blood pressure during elective cesarean section under spinal anesthesia. All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Conditions

Interventions

DRUG

Adrenaline

i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg

DRUG

Ephedrine

i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg

Sponsors & Collaborators

  • Ben marzouk Sofiene

    lead OTHER

Principal Investigators

  • HAYEN MAGHREBIG, PROFESSOR · UNIVERSITY OF TUNIS EL MANAR

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03704909 on ClinicalTrials.gov