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NCT03149588 Clinical Trial

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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03149588
Other study ID # GACS
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 3, 2017
Est. completion date November 2019

Study information
Verified date June 2018
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date November 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- ASA?or ? parturients (aged 18-35 years) undergoing elective caesarean section

Exclusion Criteria:

- Parturients with severe pregnancy complications

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• propofol
Using propofol and remifentanil as maintenance of general anesthesia during caesarean section.
• sevoflurane
Using sevoflurane and remifentanil as maintenance of general anesthesia during caesarean section.

Locations
Country Name City State
China First Affiliated Hospital, Sun Yat-sen University Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
Tao Zhang

Country where clinical trial is conducted

China, 

References & Publications (1)

Devroe S, Van de Velde M, Rex S. General anesthesia for caesarean section. Curr Opin Anaesthesiol. 2015 Jun;28(3):240-6. doi: 10.1097/ACO.0000000000000185. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal hospital stay Maternal hospital stay time Before dismissed from hospital
Primary Maternal mortality Maternal mortality in hospital Before dismissed from hospital
Primary Newborn hospital stay Newborn hospital stay time Before dismissed from hospital
Primary Newborn mortality Newborn mortality in hospital Before dismissed from hospital
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