NCT00506246

Brief Summary

The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

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

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 25, 2008

Status Verified

February 1, 2008

Enrollment Period

4 months

First QC Date

July 24, 2007

Last Update Submit

February 22, 2008

Conditions

General AnaesthesiaInduction of Anaesthesia

Keywords

anaesthesia

Outcome Measures

Primary Outcomes (2)

  • time to loss of eyelash reflex

    induction of anaesthesia

  • doses required for induction of anaesthesia until loss of eyelash reflex

    induction of anaesthesia

Secondary Outcomes (6)

  • patient data/history

    during anaesthesia

  • pre- and concomitant medication

    during anaesthesia

  • anaesthesia relating data

    during anaesthesia

  • recovery data

    during anaesthesia

  • drug safety data (e.g. haemodynamics and clinical outcome)

    during anaesthesia

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Propofol MCT/LCT

Drug: Propofol

2

ACTIVE COMPARATOR

Propofol LCT

Drug: Propofol

Interventions

PropofolDRUG

* intravenous (total intravenous anaesthesia) * induction and maintenance

Also known as: Propofol Lipuro 1%, Diprivan 1%
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male adult patients, and at least 18 and maximal 65 years of age;
  • ASA-classification I to II;
  • Undergoing an elective surgery, the anaesthesia is expected to last at least 1 hour and no more than 3 hours;
  • Will be under total intravenous anaesthesia;
  • Willing to give their signed informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pekin Union Medical College Hospital

Beijing, China

Location

Renji Hospital Affiliated to Shanghai Jiaotong University

Shanghai, China

Location

Zhongshan Hospital affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Zhanggang Xue, Prof

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 25, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 25, 2008

Record last verified: 2008-02

Locations

CN(3)