Validation of a Multimodal Indicator of Depth of Anesthesia | NCT02742012

Studies
Validation of a Multimodal Indicator of Depth of Anesthesia

NCT02742012

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

257Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

the study is observational

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Jun 25, 2015

First Submission Date that Met QC Criteria

Apr 13, 2016

First Posted Date

Apr 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2018

Last Update Posted Date

Sep 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

257Actual

Name	Type	Description	Arm Group Labels	Other Names
the study is observational	Other	the study is observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness		1 minute

Secondary Outcomes

Measure	Description	Time Frame
the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia		1 minute

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

250 adult patients scheduled for elective surgery under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eberhard F Kochs, MD	Klinikum rechts der Isar Technische Universität München	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesiologie		Bonn		53127	Germany
Klinikum rechts der Isar, Department of Anesthesiology