N/A N=100 Randomized Triple-blind Treatment

the Impact of Noise on Requirements of Anesthetics During General Anesthesia

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT02534285 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia — 3.6; 3.7 Desflurane (Vol%)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: hearing protection (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Technische Universität Dresden
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia	3.6; 3.7	—
SECONDARY Awareness Using a Structured Interview ("Modified Brice Questionnaire")	—	—

Summary

The investigators hypothesize that the noise level in the operating theatre influences the patients' requirements of anesthetics. Study subject are patients undergoing abdominal surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the inhalational anesthetic desflurane. Desflurane requirements are adjusted using neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are randomized to receive hearing protections or not.

Eligibility Criteria

Inclusion Criteria

full contractual capability
written informed consent
abdominal surgery in combined general/epidural anesthesia
position during surgery: supine
clinically normal hearing

Exclusion Criteria

history of psychiatric disease
history of intraoperative awareness
clinically impaired Hearing
contraindication for placing an epidural catheter

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02534285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.