EEG During Gastroscopy and/or Colonoscopy

NCT ID: NCT07073274

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2026-06-30

Brief 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. 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

EEG monitoring

Continuous EEG monitoring

Group Type: OTHER

EEG analysis

Intervention Type: DIAGNOSTIC_TEST

All patients will have a continous recording of their EEG during anesthesia

Interventions

EEG analysis

All patients will have a continous recording of their EEG during anesthesia

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients undergoing gastroscopy and or colonoscopy in a outpatient setting under sedation or general anesthesia

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H.U.B _ Hôpital Erasme

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Denis Schmartz, MD

Role: CONTACT

denis.schmartz@hubruxelles.be

+3225553111

Leo Jaubert, MD

Role: CONTACT

leo.jaubert@hubruxelles.be

+3225553111

Facility Contacts

Denis Schmartz, MD

Role: primary

denis.schmartz@hubruxelles.be

+3225553111

References

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.

Reference Type: BACKGROUND

PMID: 11414713 (View on PubMed)

Other Identifiers

HUB2025185

Identifier Type: -

Identifier Source: org_study_id