title: Depth of anaesthesia monitoring during procedural sedation and analgesia: a systematic review protocol.
abstract: BACKGROUND
  Procedural sedation and analgesia (PSA) is used to attenuate the pain and distress that may otherwise be experienced during diagnostic and interventional medical or dental procedures. As the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Level of consciousness is usually monitored during PSA with clinical observation. Processed electroencephalogram-based depth of anaesthesia (DoA) monitoring devices provide an alternative method to monitor level of consciousness that can be used in addition to clinical observation. However, there is uncertainty as to whether their routine use in PSA would be justified. Rigorous evaluation of the clinical benefits of DoA monitors during PSA, including comprehensive syntheses of the available evidence, is therefore required. One potential clinical benefit of using DoA monitoring during PSA is that the technology could improve patient safety by reducing sedation-related adverse events, such as death or permanent neurological disability. We hypothesise that earlier identification of lapses into deeper than intended levels of sedation using DoA monitoring leads to more effective titration of sedative and analgesic medications, and results in a reduction in the risk of adverse events caused by the consequences of over-sedation, such as hypoxaemia. The primary objective of this review is to determine whether using DoA monitoring during PSA in the hospital setting improves patient safety by reducing the risk of hypoxaemia (defined as an arterial partial pressure of oxygen below 60 mmHg or percentage of haemoglobin that is saturated with oxygen [SpO(2)] less than 90 %). Other potential clinical benefits of using DoA monitoring devices during sedation will be assessed as secondary outcomes.
  
  
  METHODS
  Electronic databases will be systematically searched for randomized controlled trials comparing the use of depth of anaesthesia monitoring devices with clinical observation of level of consciousness during PSA. Language restrictions will not be imposed. Screening, study selection and data extraction will be performed by two independent reviewers. Disagreements will be resolved by discussion. Meta-analyses will be performed if suitable.
  
  
  CONCLUSIONS
  This review will synthesise the evidence on an important potential clinical benefit of DoA monitoring during PSA within hospital settings.
  
  
  BACKGROUND
  PROSPERO CRD42015017251.
authors.affiliation: Institute of Health & Biomedical Innovation, Queensland University Technology, Kelvin Grove Campus, Kelvin Grove, Queensland, 4059, Australia. aaron.conway@qut.edu.au.|Cardiac Catheter Theatres, The Wesley Hospital, Auchenflower, Queensland, Australia. aaron.conway@qut.edu.au.
authors.forename: Aaron
authors.initials: A
authors.lastname: Conway
authors.affiliation: Coffs Harbour Health Campus, Coffs Harbour, Australia. Joanna.Sutherland@ncahs.health.nsw.gov.au.|Rural Clinical School, University of New South Wales, Sydney, Australia. Joanna.Sutherland@ncahs.health.nsw.gov.au.
authors.forename: Joanna
authors.initials: J
authors.lastname: Sutherland
mesh_terms: D000698:Analgesia; D000758:Anesthesia; D003243:Consciousness / Q000187:drug effects*; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods*; D000078202:Systematic Reviews as Topic