NCT00251810

Brief Summary

This study aims to test whether two depth-of-anaesthesia-monitors can perform equally well in monitoring anaesthetic sleep, both at induction and emergence from anaesthesia and during surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

First QC Date

November 9, 2005

Last Update Submit

August 15, 2011

Conditions

General Anaesthesia

Keywords

general anaesthesiadepth of hypnosisCerebral State MonitorCSMBispectral IndexBIS

Study Arms (1)

general anaesthesia

Device: Cerebral State Monitor

Interventions

Cerebral State MonitorDEVICE

All patients monitored with BIS and CSM, results hidden for the anesthesiologist.

general anaesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 patients undergoing general anaesthesia

You may qualify if:

  • Healthy patients undergoing surgery in general anaesthesia

You may not qualify if:

  • No ability to give written informed consent, drug abuse, patients on medication suspected or known to influence the EEG, surgery involving head or face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, Ullevaal University Hospital

Oslo, 0407, Norway

Location

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Johan Raeder, professor

    University of Oslo

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 10, 2005

Study Start

November 1, 2004

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

NO(1)