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Completed

NCT Number: NCT03775356

Reduction of Intraoperative EEG Burst Suppression

Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. This monocentric, simple masked randomized study aims primarily to investigate, whether particular anesthesiological interventions reduce the occurrence of intraoperative burst suppression. The investigator initiated trial includes 66 patients (male and female) aged ≥ 60 years in two groups (intervention and control group). Secondary aims will be the correlation of burst suppression and mean arterial pressure, concentration of anesthetics and postoperative delirium.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar - Klinik fuer Anaesthesiologie und Intensivmedizin

München, Bavaria, 81675, Germany

About this study

Intraoperative burst suppression represents a non physiological EEG pattern. According to the literature and scientific knowledge, intraoperative burst suppression patterns might be caused either by hypotension resulting in a reduced cerebral circulation or by an oversedation of anesthetics correlating with a very deep level of hypnosis.

Some publications exist that discuss the occurrence of intraoperative burst suppression especially in elderly people (aged ≥ 60 years) as a predictor of postoperative delirium and postoperative cognitive dysfunction.

None of the studies however was able to prove a causal relationship between burst suppression and postoperative delirium. Contrary it might simply be an epiphenomenon.

Conducting this interventional trail primarily aims to prove whether specific anesthesiological interventions, such as the treatment of intraoperative hypotension in first line and/or the reduction of the concentration of anesthetics in second line, reduce intraoperative burst suppression. Hence it might be possible to investigate a possible casualty between burst suppression and postoperative delirium in a second trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 60 years
  • Surgical interventions in general anesthesia (volatile or total intravenous anesthesia)
  • expected surgery duration ≥ 1h
  • American Society of Anesthesiologists (ASA) 1-4
  • written informed consent prior to study participation

Exclusion criteria

  • Neurological or psychiatric disorders
  • hearing difficulty
  • deafness
  • neurosurgical (intra)cranial surgery
  • pregnancy
  • expected continuous mandatory ventilation after surgery

Treatment and study plan

Treatment of hypotension and/or reduction of anesthetics

Other

The treatment of hypotension can be done by the responsible anesthetist according to the clinical standard operations including any accepted drug typically used in this hospital. The reduction of anesthetics can be done either by reducing the volatile end tidal anesthetics concentration (ETAC) or the infusion rate of propofol.

Primary outcomes

  1. Chance of the total, cumulative burst suppression rate.

    Time frame: During general anesthesia and within the intervention

    The total, cumulative burst suppression rate (BSR) corresponds to area under the curve and is defined by the BSR (%) and the absolute duration of BSR (t).

Secondary outcomes

  1. Burst suppression rate during induction.

    Time frame: During induction within the intervention

    Rate of change of the burst suppression rate during induction.

  2. Burst suppression rate during maintenance.

    Time frame: During maintenance within the intervention

    Rate of change of the burst suppression ratio during maintenance.

  3. Mean arterial blood pressure.

    Time frame: During burst suppression within general anesthesia

    Evaluation of the mean arterial blood pressure with positive burst suppression rate.

  4. Endtidal anesthetic concentration (ETAC) and infusion rate of propofol.

    Time frame: During burst suppression within the intervention

    Evaluation of the mean ETAC and infusion rate of propofol.

  5. Specific characteristics of the EEG frequency spectrum during burst suppression

    Time frame: During burst suppression within general anesthesia

    Evaluation of specific EEG frequencies differentiating BSR caused by hypotension or oversedation of anesthetics.

  6. Postoperative delirium.

    Time frame: Within the first three postoperative days

    Screening of the patients regarding a postoperative delirium by a brief confession assessment method (bCAM).

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy

Acronym: BsR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2018
Registry last updated
May 11, 2021

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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