Endoscopy 2016; 48(01): 42-50
DOI: 10.1055/s-0034-1393117
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study)

Peter Klare
1   II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany
,
Johanna Reiter
1   II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany
,
Alexander Meining
2   Klinik für Innere Medizin I, Universitätsklinikum Ulm, Germany
,
Stefan Wagenpfeil
3   Institut für Medizinische Biometrie, Epidemiologie und Medizinische Informatik, Universität des Saarlandes, Campus Homburg, Germany
,
Tim Kronshage
4   Medizinische Universitätsklinik des Knappschaftskrankenhaus der Ruhr-Universität Bochum, Germany
,
Christoph Geist
4   Medizinische Universitätsklinik des Knappschaftskrankenhaus der Ruhr-Universität Bochum, Germany
,
Stefan Heringlake
4   Medizinische Universitätsklinik des Knappschaftskrankenhaus der Ruhr-Universität Bochum, Germany
,
Christoph Schlag
1   II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany
,
Monther Bajbouj
1   II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany
,
Gerhard Schneider
5   Klinik für Anästhesie, Universitätsklinikum der Universität Witten/Herdecke, Helios Klinikum Wuppertal, Germany
,
Roland M. Schmid
1   II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany
,
Till Wehrmann*
6   Fachbereich Gastroenterologie, Deutsche Klinik für Diagnostik, Helios Klinik Wiesbaden, Germany
,
Stefan von Delius*
1   II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Germany
,
Andrea Riphaus*
7   Medizinische Klinik, KRH Klinikum Agnes Karll, Laatzen, Germany
› Author Affiliations
Further Information

Publication History

submitted 11 April 2015

accepted after revision 13 July 2015

Publication Date:
28 September 2015 (online)

Background and study aims: This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP).

Methods: Patients (American Society of Anesthesiologists [ASA] I – IV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sao 2] below 90 %); secondary end points included occurrences of severe hypoxemia (Sao 2 ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction).

Results: 242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, P = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, P < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, P = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups.

Conclusion: Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea.

ClinicalTrials.gov identifier: NCT01072474.

* These authors contributed equally to the study.


 
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