Electroencephalogram Based Real-Time Sedation Level Prediction

NCT05757622 | Unknown

• 1 other identifier: 16097
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Recruitment procedure:
2. 2.Monitor and recording set up:
3. 3.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.
4. 4.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.
5. 5.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.
6. 6.Sedation/Pain assessments:

Conditions

Procedural Sedation

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Propofol DRUG

Procedural sedation provided with propofol and remifentanil using target controlled infusions

Remifentanil DRUG

Procedural sedation provided with propofol and remifentanil using target controlled infusions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Interventions

Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 13, 2023

Record last verified: 2023-03