N/A
Completed N=100
the Impact of Noise on Requirements of Anesthetics During General Anesthesia
Anesthesia
Source: ClinicalTrials.gov NCT02534285 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: 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%)
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.
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") |
— | — |
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
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. Informational only — not medical advice.