NCT00455026

Brief Summary

Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 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

March 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
6 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

May 30, 2013

Status Verified

March 1, 2007

Enrollment Period

1.6 years

First QC Date

April 1, 2007

Last Update Submit

May 28, 2013

Conditions

Depth of Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Prediction probability for prediction of anaesthetic endpoints

    During induction of anaesthesia

Study Arms (3)

1

PLACEBO COMPARATOR

0 ng/ml target effect site concentration remifentanil

Drug: remifentanil

2

ACTIVE COMPARATOR

2 ng/ml target concentration remifentanil

Drug: remifentanil

3

ACTIVE COMPARATOR

4 ng/ml target effect site concentration remifentanil

Drug: remifentanil

Interventions

remifentanilDRUG

target effect site concentration during induction

Also known as: No other names
123

Eligibility Criteria

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

You may qualify if:

  • Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia

You may not qualify if:

  • Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
  • Epilepsy or other EEG abnormality
  • Prescription or illicit drugs known to affect the EEG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Swinburne University

Hawthorn, Victoria, 3123, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kate Leslie, MD

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2007

First Posted

April 3, 2007

Study Start

March 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 30, 2013

Record last verified: 2007-03

Locations

AU(2)