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OpenTrials
Completed

NCT Number: NCT07073274

EEG During 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H.U.B _ Hôpital Erasme

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG analysis

Diagnostic Test

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

Primary outcomes

  1. Burst suppression

    Time frame: 90 min

    Percentage of time spent in burst suppression

  2. PSI

    Time frame: 90 min

    Percentage of time spent in each PSI range

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

EEG Analysis During Anesthesia for Day Case Gastroscopy and/or Colonoscopy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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