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Completed

NCT Number: NCT02534285

the Impact of Noise on Requirements of Anesthetics During General Anesthesia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Dept. of Anesthesia

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing protection

Device

Attenuation of hearing during surgery

Other names: PeltorTM OptimeTM III H540A, 3M, Värnamo, Sweden

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2015
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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