NCT01091350

Brief Summary

The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

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

May 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

5 months

First QC Date

March 14, 2010

Last Update Submit

May 29, 2013

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Estimated effect-site propofol concentration at loss of consciousness

    after propofol infusion

Secondary Outcomes (1)

  • Time to loss of consciousness

    after propofol infusion

Study Arms (2)

Diprifusor group

ACTIVE COMPARATOR

Propofol was infused via Diprifusor TCI (Target-controlled infusion)

Device: Diprifusor (Target-controlled infusion)

Orchestra group

EXPERIMENTAL

Propofol was infused via Orchestra TCI

Device: Orchestra (Target-controlled infusion)

Interventions

Diprifusor (Target-controlled infusion)DEVICE

Two TCI devices with different Teo and same Marsh PK model

Also known as: Diprifusor(Grasby Medical Limited, United Kingdom)
Diprifusor group
Orchestra (Target-controlled infusion)DEVICE

Two TCI devices with different Teo and same Marsh PK model

Also known as: OrchestraTM (Fresenius Vial, Brezins, France)
Orchestra group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients undergoing general anesthesia

You may not qualify if:

  • Hepatic or renal disease
  • Drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 14, 2010

First Posted

March 24, 2010

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

May 31, 2013

Record last verified: 2013-05