title: A randomised controlled trial: can acupuncture reduce drug requirement during analgosedation with propofol and alfentanil for colonoscopy? A study protocol.
abstract: BACKGROUND
  The number of colonoscopies tremendously increased in recent years and will further rise in the near future. Because of patients' growing expectation on comfort during medical procedures, it is not surprising that the demand for sedation also expands. Propofol in combination with alfentanil is known to provide excellent analgosedation, however, its use is associated with respiratory and cardiovascular depression. Acupuncture could be a technique to reduce drug requirement while providing the same level of sedation and analgesia.
  
  
  METHODS
  The study will be performed as a single centre, randomised, placebo controlled trial. 153 patients scheduled for propofol/alfentanil sedation during colonoscopy will be randomly assigned to receive electroacupuncture (P6, ST36, LI4), sham acupuncture, or placebo acupuncture. Following endoscopy patients and gastroenterologists have to fill in questionnaires about their sedation experiences. Additionally, patients have to accomplish the Trieger test before and after the procedure. Patient monitoring includes time adapted HR, SpO2, ECG, NIBP, exCO2, OAA/S, and the Aldrete score. The primary outcome parameter is the dosage of propofol necessary for an adequate level of sedation to tolerate the procedure (OAA/S < 4). Effectiveness of sedation, classified by satisfaction levels measured by questionnaires is the secondary outcome parameter.
  
  
  CONCLUSIONS
  Moderate to deep sedation using propofol is increasingly applied during colonoscopies with a high satisfaction level among patients despite well-known hemodynamic and respiratory side effects of this hypnotic agent. Acupuncture is known to attenuate gastrointestinal discomfort and pain. We hypothesize that the combination of conventional sedation techniques with acupuncture may result in equally satisfied patients with a lower risk of respiratory and hemodynamic events during colonoscopies.
  
  
  BACKGROUND
  This trial is registered in the Nederland's Trial Register NTR 4325 . The first patient was randomized on 13 February 2014.
authors.affiliation: Department of Anaesthesiology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100, DD, The Netherlands. S.Eberl@amc.uva.nl.
authors.forename: Susanne
authors.initials: S
authors.lastname: Eberl
authors.affiliation: Department of Anaesthesiology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100, DD, The Netherlands. N.Oliveira@amc.uva.nl.
authors.forename: Nelson
authors.initials: N
authors.lastname: Monteiro de Olivera
authors.affiliation: Department of Anaesthesiology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100, DD, The Netherlands. B.Preckel@amc.uva.nl.
authors.forename: Benedikt
authors.initials: B
authors.lastname: Preckel
authors.affiliation: Department of Anaesthesiology and Pain Therapy, Inselspital, Bern, Switzerland. Konrad.Streitberger@insel.ch.
authors.forename: Konrad
authors.initials: K
authors.lastname: Streitberger
authors.affiliation: Department of Gastroenterology & Hepatology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100, DD, The Netherlands. P.Fockens@amc.uva.nl.
authors.forename: Paul
authors.initials: P
authors.lastname: Fockens
authors.affiliation: Department of Anaesthesiology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100, DD, The Netherlands. M.W.Hollmann@amc.uva.nl.
authors.forename: Markus W
authors.initials: MW
authors.lastname: Hollmann
mesh_terms: D015670:Acupuncture Therapy; D000328:Adult; D015760:Alfentanil / Q000008:administration & dosage; D003113:Colonoscopy; D016292:Procedural Sedation / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy; D017060:Patient Satisfaction; D015742:Propofol / Q000008:administration & dosage; D011795:Surveys and Questionnaires
chemical_list: D006993:Hypnotics and Sedatives; D015760:Alfentanil; D015742:Propofol