BACKGROUND
Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most complex gastrointestinal endoscopic procedures. Currently, it is still unclear which sedation regimen best facilitates an ERCP. The N-methyl-d-aspartate receptor antagonist esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less cardiorespiratory depression than other sedatives. It could therefore be an ideal adjunct to propofol for deep sedation.
OBJECTIVE
To assess the effectiveness of esketamine versus alfentanil as an adjunct to propofol target-controlled infusion (TCI) for deep sedation during ambulant ERCP.
DESIGN
A randomised controlled multicentre study.
SETTING
Endoscopic intervention suite at an academic and general hospital in the Netherlands.
PARTICIPANTS
Adult, American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo ERCP.
INTERVENTION
Consecutive patients were randomly assigned to receive sedation for an ERCP with propofol TCI and alfentanil (group A) or with propofol TCI and esketamine (group E).
MAIN OUTCOME MEASURES
The primary outcome was effectiveness of the sedation regimen expressed as the total dose of propofol – as a surrogate parameter – necessary to perform ERCP in a satisfactory manner for endoscopist and patients. Secondary outcomes were recovery time, patients’ and endoscopists’ satisfaction with sedation, side effects (e.g. psychotomimetic effects, nausea and vomiting) and the number of respiratory and cardiovascular adverse events.
RESULTS
Data from 162 patients were analysed. The total dose of propofol required was significantly lower in group E (n=83) (8.3 mg kg−1 h−1) than in group A (n=79) (10.5 mg kg−1 h−1) (P < 0.001). There were no significant differences in recovery time, patients’ and endoscopists’ satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events.
CONCLUSION
Low-dose esketamine reduces the total amount of propofol necessary for sedation during ERCP in American Society of Anesthesiologists I and II patients without affecting recovery time, satisfaction of patients and endoscopists, side effects and respiratory or cardiovascular adverse events, when compared with alfentanil.
TRIAL REGISTRATION
The Netherlands Trial Register (NTR5486).
Large mediastinal masses are rare, and encompass a wide variety of diseases. Regardless of the diagnosis, all large mediastinal masses may cause compression or invasion of vital structures, resulting in respiratory insufficiency or hemodynamic decompensation. Detailed preoperative preparation is a prerequisite for favorable surgical outcomes and should include preoperative multimodality imaging, with emphasis on vascular anatomy and invasive characteristics of the tumor. A multidisciplinary team should decide whether neoadjuvant therapy can be beneficial. Furthermore, the anesthesiologist has to evaluate the risk of intraoperative mediastinal mass syndrome (MMS). With adequate preoperative team planning, a safe anesthesiological and surgical strategy can be accomplished.
BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) is a gastrointestinal procedure that requires a relatively motionless patient during the intervention. Deep sedation by intravenous propofol combined with an opioid has recently become the preferred sedation technique. However, when high doses of propofol are used, side effects, namely respiratory depression, may occur. Esketamine has hypnotic, analgesic, and sympathomimetic effects. Our assumption is that a combination of propofol with esketamine reduces the dosage of individual drugs, thereby minimizing sedation side effects while keeping the same satisfaction level of patients and endoscopists.Methods/designThe study will be performed as a randomized controlled multicenter trial. Patients undergoing ERCP, ≥ 18 years old, with American Society of Anesthesiologists (ASA) classification I–III will be randomized after written informed consent to group K (propofol/esketamine) or to group A (propofol/alfentanil). The primary outcome, reflecting effectiveness of sedation, is the total dose of propofol. Secondary outcome parameters are patients’ and endoscopists’ satisfaction with the procedure and the number of sedation-related pulmonary and cardiovascular events. Data on sedation-related events are collected by recording of oxygen saturation (SpO2), respiratory rate (RR), end-tidal CO2 (etCO2), heart rate (HR), arrhythmias (electrocardiogram (ECG)), and non-invasive blood pressure (NIBP) measurements. Satisfaction parameters are collected by means of questionnaires before and after the procedure and on the following day.DiscussionEsketamine is known for its effective anesthetic and analgesic effects maintaining spontaneous breathing and airway reflexes. Due to an increase in sympathetic tone, hypotension and cardiac depression is less common. Unfortunately esketamine is also known for its psychotomimetic effects. We aim to demonstrate that the combination of esketamine with propofol for sedation in patients subjected to ERCP interventions is nevertheless superior to a combination of propofol with an opioid.Trial registrationNederland’s Trial Register, NTR5486. Registered on 17 September 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2197-8) contains supplementary material, which is available to authorized users.
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