NCT03775356

Reduction of Intraoperative EEG Burst Suppression

Reduction of Intraoperative EEG Burst Suppression - Test of Efficacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Burst Suppression
• EEG With Abnormally Slow Frequencies
• Postoperative Delirium

Interventions

Type	Name	Description
OTHER	Treatment of hypotension and/or reduction of anesthetics	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.

Timeline

• Start date: 2019-01-08
• Primary completion: 2020-12-19
• Completion: 2020-12-19
• First posted: 2018-12-13
• Last updated: 2021-05-11

Locations

1 site across 1 country: Germany