the Impact of Noise on Requirements of Anesthetics During General Anesthesia

NCT02534285 | Completed Results

• 1 other identifier: Dresden EK30012015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Anesthesia, Inhalation; Hearing; Noise, Occupational

Outcome Measures

Primary Outcomes (1)

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

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

  one hour

Secondary Outcomes (1)

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

  1 day

Study Arms (2)

Control

SHAM COMPARATOR

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

Device: hearing protection

Intervention

ACTIVE COMPARATOR

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

Device: hearing protection

Interventions

hearing protection DEVICE

Attenuation of hearing during surgery

Also known as: PeltorTM OptimeTM III H540A, 3M, Värnamo, Sweden

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• full contractual capability
• written informed consent
• abdominal surgery in combined general/epidural anesthesia
• position during surgery: supine
• clinically normal hearing

You may not qualify if:

• history of psychiatric disease
• history of intraoperative awareness
• clinically impaired Hearing
• contraindication for placing an epidural catheter

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

University Hospital, Dept. of Anesthesia

Dresden, 01307, Germany

Location

Related Links

• Link to the published manuscript (open access).

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Dr. Matthias Hübler
• Organization: Technical University Dresden, Dept. of Anaesthesiology

matthias.huebler@uniklinikum-dresden.de

+4945814002

Study Officials

• Matthias Hübler, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Locations

DE (1)