Electroencephalogram Based Real-Time Sedation Level Prediction (EBSPA)

Electroencephalogram Based Real-Time Sedation Level Prediction Using Artificial Intelligence

This is an observational pilot study. Patients undergoing elective surgery or Cath lab interventions under general anesthesia or procedural sedation at the department of anesthesiology at the UMCG will be enrolled.

1. Recruitment procedure:

   Patients identified as eligible for the study by research/clinical staff will be enrolled after written informed consent. Clinical staff involved in this study will approach the patient for obtaining informed consent prior to the scheduled procedure, according to the UMCG´s daily published OR/Cath lab schedule. Patients enrolled in this study will receive standard clinical care, as defined in the standard operating procedures of the department of Anesthesiology.

2. Monitor and recording set up:

   1. A vital sign monitor will continuously record routine physiological data, including ECG, noninvasive and/or invasive blood pressure (blood pressure cuff and/or arterial line), and pulse oximetry.
   2. The noninvasive EEG-monitor A disposable sensor will be attached to the forehead of the patient and passive recording of EEG and physiological data will begin prior to induction of anesthesia at the OR or Cath lab.
   3. Vital sign monitor and EEG-monitor used for this study are mounted permanently on the anesthesia machine and sedation workstation which is used routinely at the department of Anesthesiology and data obtained are directly streamed to the UMCG patient data record system , and stored monitor for case-based wave analysis.
3. Sedation/Pain assessments:

As per routine clinical practice, the investigators will use Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) scoring system for sedation assessment system for pain assessment. During each assessment MOAA/S scores will be determined prior to induction of anesthesia or sedation, during the procedure, and after the procedure until the patient leaves the operating room/cath lab.

Study Overview

• Status: Not yet recruiting
• Conditions: Procedural Sedation
• Intervention / Treatment: Drug: Propofol; Drug: Remifentanil

Detailed Description

This is an observational pilot study. Patients undergoing elective surgery or Cath lab interventions under general anesthesia or procedural sedation at the department of anesthesiology at the UMCG will be enrolled.

1. Recruitment procedure:

   Patients identified as eligible for the study by research/clinical staff will be enrolled after written informed consent. Clinical staff involved in this study will approach the patient for obtaining informed consent prior to the scheduled procedure, according to the UMCG´s daily published OR/Cath lab schedule. Patients enrolled in this study will receive standard clinical care, as defined in the standard operating procedures of the department of Anesthesiology.

2. Monitor and recording set up:

   1. A vital sign monitor will continuously record routine physiological data, including ECG, noninvasive and/or invasive blood pressure (blood pressure cuff and/or arterial line), and pulse oximetry.
   2. The noninvasive EEG-monitor A disposable sensor will be attached to the forehead of the patient and passive recording of EEG and physiological data will begin prior to induction of anesthesia at the OR or Cath lab.
   3. Vital sign monitor and EEG-monitor used for this study are mounted permanently on the anesthesia machine and sedation workstation which is used routinely at the department of Anesthesiology and data obtained are directly streamed to the UMCG patient data record system , and stored in the monitor for case-based wave analysis.
3. Sedation/Pain assessments:

As per routine clinical practice, the investigators will use Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) scoring system for sedation assessment at each level of sedation. During each assessment , MOAA/S scores will be determined prior to induction of anesthesia or sedation, during the procedure, and after the procedure until the patient leaves the operating room/cath lab.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years, undergoing elective procedures under general anesthesia or procedural sedation

Description

Inclusion Criteria:

• Patients older than 18 years, undergoing elective procedures under general anesthesia or procedural sedation

Exclusion Criteria:

• Deemed unsuitable for selection by the research team or service care providers due to any medical, legal, social, or interpersonal issues that would either compromise the study or the routine care of patients.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG	EEG recordings during procedural sedation	From 5 minutes prior to start if induction to full awakening
Vital signs	Changes in Vital signs associated with the level of procedural sedation	From 5 minutes prior to start if induction to full awakening
MOAAS score	sedation depth scoring using the MOAAS score	From 5 minutes prior to start if induction to full awakening

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: 16097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No