NCT07073274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

July 9, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

AnesthesiaEEGBurst suppressiongastroscopycolonoscopy

Outcome Measures

Primary Outcomes (2)

  • Burst suppression

    Percentage of time spent in burst suppression

    90 min

  • PSI

    Percentage of time spent in each PSI range

    90 min

Study Arms (1)

EEG monitoring

OTHER

Continuous EEG monitoring

Diagnostic Test: EEG analysis

Interventions

EEG analysisDIAGNOSTIC_TEST

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

EEG monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H.U.B _ Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 11414713BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

July 25, 2025

Primary Completion

February 15, 2026

Study Completion

February 28, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations