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Clinical Trials/NCT03149588
NCT03149588
Unknown
Phase 4

Comparison of Effects of Propofol and Sevoflurane as Maintaining Anesthetics During General Anesthesia on Maternal and Fetal Outcomes After Cesarean Section

Tao Zhang1 site in 1 country60 target enrollmentApril 3, 2017

Overview

Phase
Phase 4
Intervention
propofol
Conditions
Sevoflurane
Sponsor
Tao Zhang
Enrollment
60
Locations
1
Primary Endpoint
Maternal hospital stay
Last Updated
7 years ago

Overview

Brief Summary

Sevoflurane and propofol are the most popular drug choices for maintenance of general anaesthesia for caesarean section. However, effects of these two anesthetics on maternal and fetal outcomes after caesarean section haven't been compared directly. The aim of this study is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia, and to try to determine which anesthetic is better for maternal and fetal outcomes after caesarean section.

Detailed Description

General anaesthesia is mostly performed for emergency grade 1 caesarean section and due to a lack of time to apply a neuraxial anaesthesia technique. Rapid sequence induction using propofol and rocuronium should become the standard for general anaesthesia in the obstetric patient. Both sevoflurane and propofol are considered to be appropriate for the maintenance of general anaesthesia during caesarean section. However, effects of these two anesthetics on maternal and fetal outcomes after caesarean section haven't been compared directly in the past. And for most anaesthesiologists, the clinical experience with general anaesthesia for caesarean section is very low. This study is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia.

Registry
clinicaltrials.gov
Start Date
April 3, 2017
End Date
November 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Tao Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Tao Zhang

Clinical Professor of Department of Anesthesiology

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

  • ASAⅠor Ⅱ parturients (aged 18-35 years) undergoing elective caesarean section

Exclusion Criteria

  • Parturients with severe pregnancy complications

Arms & Interventions

propofol

Intervention: propofol

sevoflurane

Intervention: sevoflurane

Outcomes

Primary Outcomes

Maternal hospital stay

Time Frame: Before dismissed from hospital

Maternal hospital stay time

Maternal mortality

Time Frame: Before dismissed from hospital

Maternal mortality in hospital

Newborn hospital stay

Time Frame: Before dismissed from hospital

Newborn hospital stay time

Newborn mortality

Time Frame: Before dismissed from hospital

Newborn mortality in hospital

Study Sites (1)

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