Procedural SedationEBSPANCT05757622
Electroencephalogram Based Real-Time Sedation Level Prediction
An observational study of Procedural Sedation, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Propofol and Remifentanil
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 18 years, undergoing elective procedures under general anesthesia or procedural sedation
Who may be able to join
- Patients older than 18 years, undergoing elective procedures under general anesthesia or procedural sedation
Who cannot join
- 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.
About this study
Official title: 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.
- 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.
- Monitor and recording set up:
- 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.
- 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.
- 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.
- 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.
Read the 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.
- 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.
- Monitor and recording set up:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Procedural Sedation
- Being tested
- Propofol, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Procedural sedation provided with propofol and remifentanil using target controlled infusions
RemifentanilDrug
Procedural sedation provided with propofol and remifentanil using target controlled infusions
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
EEG recordings during procedural sedation
Measured: From 5 minutes prior to start if induction to full awakening
Vital signs
Changes in Vital signs associated with the level of procedural sedation
Measured: From 5 minutes prior to start if induction to full awakening
MOAAS score
sedation depth scoring using the MOAAS score
Measured: From 5 minutes prior to start if induction to full awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757622
- Sponsor's protocol ID
- 16097
- Acronym
- EBSPA
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalogram Based Real-Time Sedation Level Prediction Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT05757622
- Acronym / sponsor ID
- EBSPA / 16097
- Conditions
- Procedural Sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Monitor and recording set up:
- 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.
- 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.
- 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.
- 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.
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.
- 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.
- Monitor and recording set up:
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years, undergoing elective procedures under general anesthesia or procedural sedation
Key inclusion criteria (1 listed)
- Patients older than 18 years, undergoing elective procedures under general anesthesia or procedural sedation
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolProcedural sedation provided with propofol and remifentanil using target controlled infusions | Drug | – |
| RemifentanilProcedural sedation provided with propofol and remifentanil using target controlled infusions | Drug | – |
Primary outcome
EEG
Time frame: From 5 minutes prior to start if induction to full awakening
EEG recordings during procedural sedation
Vital signs
Time frame: From 5 minutes prior to start if induction to full awakening
Changes in Vital signs associated with the level of procedural sedation
MOAAS score
Time frame: From 5 minutes prior to start if induction to full awakening
sedation depth scoring using the MOAAS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Sedation, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: From 5 minutes prior to start if induction to full awakening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.