the Impact of Noise on Requirements of Anesthetics During General Anesthesia

July 21, 2020 updated by: Technische Universität Dresden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • University Hospital, Dept. of Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control
Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.
Device: hearing protection
Attenuation of hearing during surgery
Other Names:
  • PeltorTM OptimeTM III H540A, 3M, Värnamo, Sweden
ACTIVE_COMPARATOR: Intervention
Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.
Device: hearing protection
Attenuation of hearing during surgery
Other Names:
  • PeltorTM OptimeTM III H540A, 3M, Värnamo, Sweden

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awareness Using a Structured Interview ("Modified Brice Questionnaire")
Time Frame: 1 day
Using a structured interview ("modified Brice questionnaire") to detect episodes of intraoperative awareness
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Matthias Hübler, MD, Consultant Dept. of Anesthesia; University Hospital Dresden; Technische Universität Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (ESTIMATE)

August 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dresden EK30012015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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