the Impact of Noise on Requirements of Anesthetics During General Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: hearing protection

• Registration Number: NCT02534285
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2020-07
• Results First Submitted: 2020-07-21
• Results First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Results First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	hearing protection	Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.
Intervention	hearing protection	Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.

Primary Outcome Measures

Name	Time	Method
Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia	one hour	Aimed BIS-index is 50, desflurane is measured in expiratory volume percentage

Secondary Outcome Measures

Name	Time	Method
Awareness Using a Structured Interview ("Modified Brice Questionnaire")	1 day	Using a structured interview ("modified Brice questionnaire") to detect episodes of intraoperative awareness

Trial Locations

Locations (1)

University Hospital, Dept. of Anesthesia; 🇩🇪 Dresden, Germany