Skip to main content
Clinical Trials/NCT02534285
NCT02534285
Completed
Not Applicable

the Impact of Noise on Requirements of Anesthetics During General Anesthesia

Technische Universität Dresden1 site in 1 country100 target enrollmentAugust 2015
ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Technische Universität Dresden
Enrollment
100
Locations
1
Primary Endpoint
Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Detailed Description

All patients receive standardized anesthesia and monitoring according to the usual clinical care in the department. Placement of epidural catheters takes place before induction of general anesthesia. Thereafter, 10 ml ropivacaine 0.3% with 10 µg sufentanil are administered epidurally every 60 min to induce and maintain analgesia during surgery. Following induction of general anesthesia and tracheal Intubation, intraoperative hypnosis is maintained using desflurane.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
November 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia

Time Frame: one hour

Aimed BIS-index is 50, desflurane is measured in expiratory volume percentage

Secondary Outcomes

  • Awareness Using a Structured Interview ("Modified Brice Questionnaire")(1 day)

Study Sites (1)

Loading locations...

Similar Trials