NCT02554175

Brief Summary

The aim of this study was to determine the target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic adverse effects associated with these propofol target concentrations.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

August 26, 2015

Last Update Submit

September 17, 2015

Conditions

C.Delivery; Surgery (Previous), Gynecological

Keywords

PropofolSchnider model

Outcome Measures

Primary Outcomes (1)

  • target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients

    up to 24 months

Study Arms (1)

the target propofol concentration

EXPERIMENTAL

patients were allocated to 1 of 6 groups of predefined propofol target Ce for induction, namely, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 µg.mL-1.Propofol was administered to achieve target propofol Ce.

Drug: Propofol

Interventions

PropofolDRUG

Propofol was administered to achieve target propofol Ce

the target propofol concentration

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty-six women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.

You may not qualify if:

  • Diabetes controlled by insulin
  • Preeclampsia
  • Heart diseases
  • History of taking drugs potentially affecting cardiovascular system.
  • Patients fasted for at least 8 hours before surgery and no premedication was given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Shaoqiang Huang

    Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China

    STUDY DIRECTOR

Central Study Contacts

Shen Sun

CONTACT

sunshen1980@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics and Gynecology Hospital

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 18, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

September 18, 2015

Record last verified: 2015-09