Validation of a Multimodal Indicator of Depth of Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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the study is observational

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No