Validation of a Multimodal Indicator of Depth of Anesthesia
Completed
- Conditions
- Anesthesia
- Registration Number
- NCT02742012
- Lead Sponsor
- Technical University of Munich
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness 1 minute
- Secondary Outcome Measures
Name Time Method the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia 1 minute
Trial Locations
- Locations (3)
Klinik für Anästhesiologie am Helios Klinikum
🇩🇪Wuppertal, Germany
Klinik für Anästhesiologie
🇩🇪Bonn, Germany
Klinikum rechts der Isar, Department of Anesthesiology
🇩🇪Munich, Germany