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

NCT ID: NCT03149588

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Sevoflurane Propofol Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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propofol

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

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

sevoflurane

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

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

Interventions

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propofol

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

Intervention Type DRUG

sevoflurane

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Parturients with severe pregnancy complications
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tao Zhang

OTHER

Sponsor Role lead

Responsible Party

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Tao Zhang

Clinical Professor of Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Wen-Qi Huang, MD.

Role: primary

15323365314

References

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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.

Reference Type BACKGROUND
PMID: 25827280 (View on PubMed)

Other Identifiers

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GACS

Identifier Type: -

Identifier Source: org_study_id

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