Cargando…

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

BACKGROUND: 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. The aim of this trial is to...

Descripción completa

Detalles Bibliográficos
Autores principales: Eberl, Susanne, Preckel, Benedikt, Bergman, Jacques J, Hollmann, Markus W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3922843/
https://www.ncbi.nlm.nih.gov/pubmed/24377675
http://dx.doi.org/10.1186/1471-230X-13-176
_version_ 1782303517338238976
author Eberl, Susanne
Preckel, Benedikt
Bergman, Jacques J
Hollmann, Markus W
author_facet Eberl, Susanne
Preckel, Benedikt
Bergman, Jacques J
Hollmann, Markus W
author_sort Eberl, Susanne
collection PubMed
description BACKGROUND: 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. 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. METHODS: The 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, SO(2), ECG, NIBP, exCO(2,) 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”. DISCUSSION: The 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 REGISTRATION: This 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.
format Online
Article
Text
id pubmed-3922843
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-39228432014-02-13 Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial Eberl, Susanne Preckel, Benedikt Bergman, Jacques J Hollmann, Markus W BMC Gastroenterol Study Protocol BACKGROUND: 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. 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. METHODS: The 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, SO(2), ECG, NIBP, exCO(2,) 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”. DISCUSSION: The 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 REGISTRATION: This 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. BioMed Central 2013-12-30 /pmc/articles/PMC3922843/ /pubmed/24377675 http://dx.doi.org/10.1186/1471-230X-13-176 Text en Copyright © 2013 Eberl et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Eberl, Susanne
Preckel, Benedikt
Bergman, Jacques J
Hollmann, Markus W
Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial
title Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial
title_full Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial
title_fullStr Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial
title_full_unstemmed Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial
title_short Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial
title_sort safety and effectiveness using dexmedetomidine versus propofol tci sedation during oesophagus interventions: a randomized trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3922843/
https://www.ncbi.nlm.nih.gov/pubmed/24377675
http://dx.doi.org/10.1186/1471-230X-13-176
work_keys_str_mv AT eberlsusanne safetyandeffectivenessusingdexmedetomidineversuspropofoltcisedationduringoesophagusinterventionsarandomizedtrial
AT preckelbenedikt safetyandeffectivenessusingdexmedetomidineversuspropofoltcisedationduringoesophagusinterventionsarandomizedtrial
AT bergmanjacquesj safetyandeffectivenessusingdexmedetomidineversuspropofoltcisedationduringoesophagusinterventionsarandomizedtrial
AT hollmannmarkusw safetyandeffectivenessusingdexmedetomidineversuspropofoltcisedationduringoesophagusinterventionsarandomizedtrial