the Impact of Noise on Requirements of Anesthetics During General Anesthesia

NCT ID: NCT02534285

Last Updated: 2020-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

Patients of the control group receive a Sham hearing protection with no effect on noise attenuation.

Group Type SHAM_COMPARATOR

hearing protection

Intervention Type DEVICE

Attenuation of hearing during surgery

Intervention

Patients of the Intervention group receive a Hearing protection with a noise attenuation of 20-45 decibel.

Group Type ACTIVE_COMPARATOR

hearing protection

Intervention Type DEVICE

Attenuation of hearing during surgery

Interventions

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hearing protection

Attenuation of hearing during surgery

Intervention Type DEVICE

Other Intervention Names

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PeltorTM OptimeTM III H540A, 3M, Värnamo, Sweden

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Hübler, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Dept. of Anesthesia; University Hospital Dresden; Technische Universität Dresden

Locations

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University Hospital, Dept. of Anesthesia

Dresden, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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Dresden EK30012015

Identifier Type: -

Identifier Source: org_study_id

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