NCT03149588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

2.4 years

First QC Date

May 5, 2017

Last Update Submit

June 9, 2018

Conditions

SevofluranePropofolCesarean Section

Outcome Measures

Primary Outcomes (4)

  • Maternal hospital stay

    Maternal hospital stay time

    Before dismissed from hospital

  • Maternal mortality

    Maternal mortality in hospital

    Before dismissed from hospital

  • Newborn hospital stay

    Newborn hospital stay time

    Before dismissed from hospital

  • Newborn mortality

    Newborn mortality in hospital

    Before dismissed from hospital

Study Arms (2)

propofol

EXPERIMENTAL
Drug: propofol

sevoflurane

EXPERIMENTAL
Drug: sevoflurane

Interventions

propofolDRUG

Using propofol and remifentanil as maintenance of general anesthesia during caesarean section.

propofol
sevofluraneDRUG

Using sevoflurane and remifentanil as maintenance of general anesthesia during caesarean section.

sevoflurane

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Parturients with severe pregnancy complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

Related 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.

    PMID: 25827280BACKGROUND

MeSH Terms

Interventions

PropofolSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor of Department of Anesthesiology

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 11, 2017

Study Start

April 3, 2017

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

CN(1)