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

• Sponsor: Tao Zhang (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03149588
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sevoflurane; Propofol; Cesarean Section	Drug: propofol; Drug: sevoflurane	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Effects of Propofol and Sevoflurane as Maintaining Anesthetics During General Anesthesia on Maternal and Fetal Outcomes After Cesarean Section
• Actual Study Start Date: Apr 3, 2017
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: propofol	Drug: propofol; Using propofol and remifentanil as maintenance of general anesthesia during caesarean section.
Experimental: sevoflurane	Drug: sevoflurane; Using sevoflurane and remifentanil as maintenance of general anesthesia during caesarean section.

Outcome Measures

Primary Outcome Measures

1. Maternal hospital stay [Before dismissed from hospital]

   Maternal hospital stay time

2. Maternal mortality [Before dismissed from hospital]

   Maternal mortality in hospital

3. Newborn hospital stay [Before dismissed from hospital]

   Newborn hospital stay time

4. Newborn mortality [Before dismissed from hospital]

   Newborn mortality in hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Parturients with severe pregnancy complications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Sun Yat-sen University	Guangzhou		China

Sponsors and Collaborators

• Tao Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Tao Zhang, Clinical Professor of Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT03149588
• Other Study ID Numbers: GACS
• First Posted: May 11, 2017
• Last Update Posted: Jun 12, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Propofol; Sevoflurane

Study Results

No Results Posted as of Jun 12, 2018