Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial

Susanne Eberl,Jacques J Bergman,Markus W Hollmann,Benedikt Preckel

doi:10.1186/1471-230x-13-176

Susanne Eberl, Jacques J Bergman + Show 2 more

Open Access

https://doi.org/10.1186/1471-230x-13-176

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Abstract

BackgroundEndoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions.MethodsThe study will be performed as a randomized controlled trial. The first 64 consenting patients will be randomized to either the propofol or the dexmedetomidine group. Following endoscopy patients and gastroenterologists have to fill in questionnaires (PSSI, CSSI) (see abbreviations) about their sedation experiences. Additionally, patients have to accomplish the Trieger test before and after the procedure. Patient monitoring includes time adapted HR, SO2, ECG, NIBP, exCO2, NICO, sweat conductance measurement, OAA/S, and the Aldrete score. Effectiveness of sedation, classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter. Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter “safety”.DiscussionThe acceptance level among patients after propofol sedation is high. Dexmedetomidine is a relatively new representative for procedural sedation. Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions?Trial registrationThis trial is registered in the ISRCTN Register (ISRCTN 68599804). It will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Departments of Anesthesiology and Gastroenterology & Hepatology of the Academic Medical Center of Amsterdam are responsible for the design and conduct of the trial.

Highlights

Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection
The following were considered as significant events: a decline in SpO2 to less than 90%, breathing frequency less than 6 breath/min, or an increase of etCO2 > 50 mmHg; a change in heart rate to less or more than 20% of baseline or occurrence of any arrhythmia’s; blood pressure less or more than 20% of the first blood pressure determined
Primary objective The primary aim of this prospective randomized controlled study is to determine, whether dexmedetomidine is more effective for sedation during endoscopic oesophageal interventions than our in house standard regime with propofol Target Controlled Infusion (TCI)

Summary

Introduction

Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. One approach is radiofrequency ablation (RFA) [6] These procedures are long lasting, uncomfortable and stressful for most patients. They require patients being sedated, but arousable in order to provide excellent view to the oesophagus. Patients receiving dexmedetomidine are arousable, yet appear calm and comfortable. When they remain unstimulated, patients return to a hypnotic state. Dexmedetomidine provides hemodynamic stability and appears to have no clinically important adverse effects on respiration [10]

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