Completed

EndoBreathCapnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP

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What is being tested

Capnography

+ Standard monitoring

Procedure
Who is being recruted

Hypoxia+1

+ Signs and Symptoms

+ Signs and Symptoms, Respiratory

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: February 2010
See protocol details

Summary

Principal SponsorTechnical University of Munich
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2010

Actual date on which the first participant was enrolled.

In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Official TitleCapnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP
NCT01072474
Principal SponsorTechnical University of Munich
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

242 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypoxiaSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
Age>=18
Scheduled for colonoscopy with midazolam and propofol sedation
4 exclusion criteria prevent from participating
ASA V
Pregnancy
No informed consent
Prexisting hypotension, bradycardia or hypoxemia

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Arm with capnographic monitoring

Group II

Placebo
Standard monitoring.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Technische Universität München

Munich, GermanyOpen Technische Universität München in Google Maps
Suspended

Knappschaftskrankenhaus der Ruhr-Universität Bochum

Bochum, Germany
Suspended

Deutsche Klinik für Diagnostik

Wiesbaden, Germany
Completed3 Study Centers