Validation of a Multimodal Indicator of Depth of Anesthesia

Technical University of Munich

Status: Completed

Conditions: Anesthesia

Treatments: Other: the study is observational

Study type: Observational

Funder types: Other

Identifiers

NCT02742012

AMI-1250-KIE-0250-I

Details and patient eligibility

About

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.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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