Comparison of Propofol and Sevoflurane as Maintaining Anesthetics During General Anesthesia of Cesarean Section

Phase 4

• Conditions: Cesarean Section; Sevoflurane; Propofol
• Interventions: Drug: sevoflurane; Drug: propofol

• Registration Number: NCT03149588
• Lead Sponsor: Tao Zhang

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.

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-09
• Last Update Posted: 2018-06-12
• Primary Completion: 2019-09
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Parturients with severe pregnancy complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane	sevoflurane	-
propofol	propofol	-

Primary Outcome Measures

Name	Time	Method
Maternal hospital stay	Before dismissed from hospital	Maternal hospital stay time
Maternal mortality	Before dismissed from hospital	Maternal mortality in hospital
Newborn hospital stay	Before dismissed from hospital	Newborn hospital stay time
Newborn mortality	Before dismissed from hospital	Newborn mortality in hospital

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China