NCT02742012

Brief Summary

The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28). The indicator previously developed shall now be tested on an independent set of data. The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers. The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

3 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

June 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

June 25, 2015

Last Update Submit

September 10, 2018

Conditions

Anesthesia

Keywords

electroencephalogramhemodynamic monitoringrespiratory monitoring

Outcome Measures

Primary Outcomes (1)

  • ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness

    1 minute

Secondary Outcomes (1)

  • the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia

    1 minute

Interventions

the study is observationalOTHER

the study is observational

Eligibility Criteria

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

250 adult patients scheduled for elective surgery under general anesthesia

You may qualify if:

  • age ≥ 18 years
  • elective surgery under general anesthesia
  • anticipated operating time of about one hour or longer
  • ASA physical status I-III
  • written informed consent

You may not qualify if:

  • chronic intake of CNS affecting drugs
  • alcohol or drug abuse in the last three months
  • CNS or psychiatric disease
  • hardness of hearing or deafness
  • abnormal gastrointestinal motility
  • non-adherence to fasting guidelines, emergency surgery
  • anticipated difficult airway
  • pregnancy
  • cardiac surgery and surgery involving the head and/or neck
  • postoperatively prolonged intubation
  • pre- and/or postoperative intensive care treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinik für Anästhesiologie

Bonn, 53127, Germany

Location

Klinikum rechts der Isar, Department of Anesthesiology

Munich, 81675, Germany

Location

Klinik für Anästhesiologie am Helios Klinikum

Wuppertal, 42283, Germany

Location

Study Officials

  • Eberhard F Kochs, MD

    Klinikum rechts der Isar Technische Universität München

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

June 25, 2015

First Posted

April 18, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

DE(3)