NCT00290108

Brief Summary

The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

February 10, 2006

Status Verified

June 1, 1998

First QC Date

February 9, 2006

Last Update Submit

February 9, 2006

Conditions

Elective SurgeryHealthy

Keywords

BISPropofolhemodynamicpharmacokinetic

Outcome Measures

Primary Outcomes (1)

  • maximum hypnotic effect as indicated by the minimum BIS value.

Secondary Outcomes (6)

  • time to loss of consciousness

  • time to loss of eye lash reflex

  • time to BISmin

  • BIS at LOC

  • BIS at LOL

  • +1 more secondary outcomes

Interventions

PropofolDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • scheduled for elective surgery under general anesthesia.

You may not qualify if:

  • emergency surgery
  • obesity
  • indication for rapid sequence induction
  • drugs that affect the central nervous system
  • history of alcohol or drug abuse
  • neurological or psychiatric diseases
  • contraindications against the use of propofol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Eberhard Kochs, MD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

March 1, 2003

Study Completion

December 1, 2003

Last Updated

February 10, 2006

Record last verified: 1998-06

Locations

DE(1)