Efficacy and Safety Study of Two Propofol Formulations | NCT00506246

Studies
Efficacy and Safety Study of Two Propofol Formulations

NCT00506246

Sponsor

B. Braun Melsungen AG

Status

Completed

Last Update Posted

Feb 25, 2008Estimated

Enrollment

220Estimated

Phase

Phase 3

Conditions

General Anaesthesia
Induction of Anaesthesia

Interventions

Propofol

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

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jul 24, 2007

First Submission Date that Met QC Criteria

Jul 24, 2007

First Posted Date

Jul 25, 2007Estimated

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

Feb 22, 2008

Last Update Posted Date

Feb 25, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

B. Braun Melsungen AGINDUSTRY

Collaborators

Name	Class
B. Braun Medical International Trading Company Ltd.	INDUSTRY
Tigermed Consulting Co., Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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

Detailed Description

Propofol (chemical substance 2, 6-Diisopropylphenol) is a short-acting intravenous general anaesthetic which is used for induction and maintenance of a general anaesthesia, for long-term sedation of ventilated intensive care patients or for short-term sedation in diagnostic and surgical procedures. As an active substance propofol produces good and readily controlled anaesthesia with smooth and problem-free recovery both in adult patients and in children over 1 month of age. One potential advantage of this formulation is that the MCT/LCT-emulsion reduces pain on injection, a frequently reported adverse reaction with LCT-emulsions of propofol.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Propofol MCT/LCT	Drug: Propofol
2	Active Comparator	Propofol LCT	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	intravenous (total intravenous anaesthesia) induction and maintenance	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
patient data/history		during anaesthesia
pre- and concomitant medication		during anaesthesia
anaesthesia relating data

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhanggang Xue, Prof	Shanghai Zhongshan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pekin Union Medical College Hospital		Beijing			China
Renji Hospital Affiliated to Shanghai Jiaotong University

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

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

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Browse Branches

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