Endoscopy of Stomach (Procedure)NCT07073274
EEG During Gastroscopy and/or Colonoscopy
A study testing EEG analysis in people with Endoscopy of Stomach (Procedure) and Colonoscopy (Procedure), run by Erasme University Hospital at 1 site in Belgium.
Trial summary
During anesthesia, EEG shows specific and significant changes according to the depth of anesthesia and the drugs used. Endoscopic procedures like gastroscopies or colonoscopies are usually done on an outpatient basis using essentially propofol for sedation or anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy of Stomach (Procedure), Colonoscopy (Procedure), Continuous Processed Electroencephalogram (Procedure)
- What is being tested?
- EEG analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jul 2025to 28 Feb 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing gastroscopy and or colonoscopy in a outpatient setting under sedation or general anesthesia
Who cannot join
- Patients < 18 years
- altered renal function, Glomerular filtration rate < 50 mL/min/m2
- altered hepatic tests, > 1.5 * upper normal limit
- Any form of hepatic cirrhosis
- Presence of oesophageal varices
- Any neurological pathology rendering EEG analysis non reliable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG Analysis During Anesthesia for Day Case Gastroscopy and/or Colonoscopy
During anesthesia, EEG shows specific and significant changes according to the depth of anesthesia and the drugs used. Endoscopic procedures like gastroscopies or colonoscopies are usually done on an outpatient basis using essentially propofol for sedation or anesthesia. Preliminary reports have shown that the depth of anesthesia during these procedures may be very deep resulting even in a burst suppression pattern on the EEG.
In this study, frontal EEG will be recorded continuously using a Root - Sedline device (Masimo, US). Anesthesiologists will be free to use the medications and dosage they judge appropriate. The attending anesthesiologist will be blinded to the EEG. Medications and dosages will be recorded, as well as processed EEG data from the Sedline and the raw EEG. Primary outcome is the % of time spend in specific range of patient state index (PSI 0-10; 10-20; 20-30; 30-40; 40-50; 5-60; 60-70; 70-80; 80-90; 90-100) as well as the % of time spent in burst suppression.
- Conditions
- Endoscopy of Stomach (Procedure), Colonoscopy (Procedure), Continuous Processed Electroencephalogram (Procedure)
- Being tested
- EEG analysis
- Keywords
- Anesthesia, EEG, Burst suppression, gastroscopy, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG analysisDiagnostic test
All patients will have a continous recording of their EEG during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| EEG monitoring | Other | Continuous EEG monitoring Receives: Diagnostic Test: EEG analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burst suppression
Percentage of time spent in burst suppression
Measured: 90 min
PSI
Percentage of time spent in each PSI range
Measured: 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start25 Jul 2025
- Primary completion15 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopy of Stomach (Procedure)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073274
- Sponsor's protocol ID
- HUB2025185
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
John ER, Prichep LS, Kox W, Valdes-Sosa P, Bosch-Bayard J, Aubert E, Tom M, di Michele F, Gugino LD. Invariant reversible QEEG effects of anesthetics. Conscious Cogn. 2001 Jun;10(2):165-83. doi: 10.1006/ccog.2001.0507.
PubMed 11414713
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Analysis During Anesthesia for Day Case Gastroscopy and/or Colonoscopy
- ClinicalTrials.gov ID
- NCT07073274
- Acronym / sponsor ID
- HUB2025185
- Conditions
- Endoscopy of Stomach (Procedure), Colonoscopy (Procedure), Continuous Processed Electroencephalogram (Procedure)
- Keywords
- Anesthesia, EEG, Burst suppression, gastroscopy, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 18 Jul 2025 (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.
During anesthesia, EEG shows specific and significant changes according to the depth of anesthesia and the drugs used. Endoscopic procedures like gastroscopies or colonoscopies are usually done on an outpatient basis using essentially propofol for sedation or anesthesia. Preliminary reports have shown that the depth of anesthesia during these procedures may be very deep resulting even in a burst suppression pattern on the EEG.
In this study, frontal EEG will be recorded continuously using a Root - Sedline device (Masimo, US). Anesthesiologists will be free to use the medications and dosage they judge appropriate. The attending anesthesiologist will be blinded to the EEG. Medications and dosages will be recorded, as well as processed EEG data from the Sedline and the raw EEG. Primary outcome is the % of time spend in specific range of patient state index (PSI 0-10; 10-20; 20-30; 30-40; 40-50; 5-60; 60-70; 70-80; 80-90; 90-100) as well as the % of time spent in burst suppression.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG monitoring | Other | Diagnostic Test: EEG analysisContinuous EEG monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing gastroscopy and or colonoscopy in a outpatient setting under sedation or general anesthesia
Key exclusion criteria (6 listed)
- Patients < 18 years
- altered renal function, Glomerular filtration rate < 50 mL/min/m2
- altered hepatic tests, > 1.5 * upper normal limit
- Any form of hepatic cirrhosis
- Presence of oesophageal varices
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 |
|---|---|---|
| EEG analysisAll patients will have a continous recording of their EEG during anesthesia | Diagnostic test | EEG monitoring |
Primary outcome
Burst suppression
Time frame: 90 min
Percentage of time spent in burst suppression
PSI
Time frame: 90 min
Percentage of time spent in each PSI range
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 11414713John ER, Prichep LS, Kox W, Valdes-Sosa P, Bosch-Bayard J, Aubert E, Tom M, di Michele F, Gugino LD. Invariant reversible QEEG effects of anesthetics. Conscious Cogn. 2001 Jun;10(2):165-83. doi: 10.1006/ccog.2001.0507.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG analysis in people with Endoscopy of Stomach (Procedure) and Colonoscopy (Procedure), run by Erasme University Hospital at 1 site in Belgium.
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 6 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Burst suppression (time frame: 90 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07073274, which also lists 1 linked publication.
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 18 Mar 2026.