EEG During Gastroscopy and/or Colonoscopy

Not Applicable

Not yet recruiting

• Conditions: Endoscopy of Stomach (Procedure); Colonoscopy (Procedure); Continuous Processed Electroencephalogram (Procedure)

• Registration Number: NCT07073274
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-09-01
• Primary Completion: 2026-05-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Burst suppression	90 min	Percentage of time spent in burst suppression
PSI	90 min	Percentage of time spent in each PSI range

Trial Locations

Locations (1)

H.U.B _ Hôpital Erasme; 🇧🇪 Brussels, Belgium