EEG-based Depth of Anesthesia-monitoring, Effects on Dosage and Cognition

Postoperative Complications Clinical Trial

Official title:

EEG-based Depth of Anesthesia-monitoring During General Anesthesia - Effects on Time to Wake-up and Post-operative Cognition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529304
• Other study ID #: 2019/32173
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: December 20, 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: Anders Aasheim, Master
• Phone: +4748129280
• Email: uxanim[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Depth of anesthesia-monitoring based on EEG changes demands knowledge about the effects of the different anesthetic medications on EEG waveforms. The investigators want to investigate the use of the raw-EEG waveform in addition to indexes (BIS) and EEG spectrogram analyses for depth of anesthesia monitoring. The investigators hypothesize that with the use of this monitoring, anaesthesia providers will be able to better individualize the dosage of anesthetic drugs, and that this will reduce the total consumption of anesthetic medication , thus reducing time to wake-up after surgery. Some studies have indicated that too deep anesthesia, confirmed by "burst-suppression" or isoelectric-EEG , is associated with increased postoperative cognitive dysfunction (POCD). The investigators will therefore assess the patients with the Cambridge Neuropsychological Test Automated Battery tests in mild cognitive impairment (CANTAB-MCI) cognitive function assessment tool.

Description:

It has been over 80 years since Gibbs et al showed how the electroencephalogram (EEG) systematically changed in concurrence with increasing doses of hypnotic drugs such as penthobarbital and Ether. The study concluded that "Electroencephalography may therefore be of value in controlling depth of anesthesia and sedation". In spite of a solid documentation of the systematic connection between dosing of anesthetic drugs, EEG-patterns and level of sedation/anesthesia , EEG-based DoA has not become a part of standard of care in anesthetic management. There is abundant evidence of how different anesthetic drugs leads to characteristic fluctuations in human brain electrical activity, relating to depth of anesthesia, anesthetic drug of choice, and age . These anesthetic induced fluctuations are readily visible as changes in the patients EEG.

Anesthetic drugs are usually administered in pharmacological models based on a population taking into account their age, weight and height. However, there is a significant difference in how patients respond to these models. In adults there is evidence that the doses needed to achieve consciousness varies with a factor of 2 above and below suggested doses. In under-dosing of anesthetics there is a risk of peroperative awareness . On the other hand there is also evidence that overdosing of anesthetics has harmful effects; children receiving more than 4% Sevoflurane can demonstrate epileptiform activity , and adults overdosing into "burst suppression" during anesthesia has a higher risk of postoperative delirium (POD) and increased occurrence of postoperative cognitive dysfunction (POCD) .

Bispectral Index (BIS) is an algorithm developed by Aspect Medical Systems in 1994, which is based on weighted sums of EEG subparameters to present an index from 0 to 100 for depth of anesthesia, where 100 is wide awake, and 0 is an isoelectric EEG. The BIS target for a deep enough anesthesia is set to be between 40 and 60. The BIS number is often in concurrence with other clinical observations related to anesthetic depth, however there is also an experience of divergence. BIS and other EEG-based indices are programmed from adult cohorts, and cannot be directly trusted in children, or the elderly . There is also an incapability in these preprogrammed indices (BIS and other) to integrate how specific anesthetic drugs affect the EEG, and thenceforth the BIS value. An example of this is how the drug Ketamine induces a specific gamma-frequency in the EEG, which the BIS-index translate as a lighter anesthesia, even though the drug is administered "on top of" an already deep level of anesthesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria

.

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

1. Participant must be above the age of 18 years , at the time of signing the informed consent.

Sex

2. Male and/or female

Informed Consent

3. Capable of giving signed informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

4. Psychiatric disorders

5. Pregnancy

6. Breast feeding

7. Using antiepileptic drugs.

8. Central neurological disease

9. Unable to complete baseline CANTAB-test.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delayed Emergence from Anesthesia
• Postoperative Complications

Intervention

Device:
• Bilateral Bispectral Index and EEG
raw-EEG and spectrographic EEG-visualization based on the Medtronic Device "Bilateral BiSpectral Index"

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG-based Depth of anesthesia-monitoring and dosage of anesthetic medications	Summarizing the total amount of anesthetic drugs used, mg/kg/hr	24 hours
Primary	EEG-based Depth of anesthesia-monitoring and dosage of vasopressor medications during anesthesia	Summarizing the total amount of vasopressor drugs used, micg/kg/min	24 hours
Primary	EEG-based Depth of anesthesia-monitoring and time to wake-up after surgery	Time from the end of intravenous infusion of anesthetic - to motoric and verbal response.	24 hours
Primary	Evaluation of cognitive function using CANTAB-MCI	Baseline assessment 1 day preoperatively, assessment 2-3 hours after wake-up, and 24 hours after wake-up using CANTAB-MCI	1 day preoperatively to 24 hours after wake-up