NCT02742012CompletedNot Applicable
A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters
Technical University of Munich3 sites in 1 country257 target enrollmentStarted: June 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 257
- Locations
- 3
- Primary Endpoint
- ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
Time Frame: 1 minute
Secondary Outcomes
- the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia(1 minute)
Investigators
Andreas Ranft
Dr. med.
Technical University of Munich
Study Sites (3)
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