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NCT02534285 Clinical Trial

the Impact of Noise on Requirements of Anesthetics During General Anesthesia

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02534285
Other study ID # Dresden EK30012015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date November 2016

Study information
Verified date July 2020
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• hearing protection
Attenuation of hearing during surgery

Locations
Country Name City State
Germany University Hospital, Dept. of Anesthesia Dresden

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Awareness Using a Structured Interview ("Modified Brice Questionnaire") Using a structured interview ("modified Brice questionnaire") to detect episodes of intraoperative awareness 1 day
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