Comparison of Propofol and Sevoflurane as Maintaining Ane... | NCT03149588

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

NCT03149588

Sponsor

Tao Zhang

Status

Unknown status

Last Update Posted

Jun 12, 2018Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Sevoflurane
Propofol
Cesarean Section

Interventions

propofol
sevoflurane

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2017Actual

Primary Completion Date

Sep 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

May 5, 2017

First Submission Date that Met QC Criteria

May 10, 2017

First Posted Date

May 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2018

Last Update Posted Date

Jun 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tao Zhang, Clinical Professor of Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen UniversitySponsor-Investigator

Lead Sponsor

Tao ZhangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propofol	Experimental		Drug: propofol
sevoflurane	Experimental		Drug: sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug	Using propofol and remifentanil as maintenance of general anesthesia during caesarean section.	propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Parturients with severe pregnancy complications

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital, Sun Yat-sen University	Recruiting	Guangzhou			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25827280	Background	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.

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic