Clinical Trial: Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An International Multi-Centre Cohort Study of the Incidence of Anaesthesia Awareness Following Laryngoscopy and Intubation: The CONSciousness, Connectedness and IntraOpera

Brief Summary: A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence of awareness with recall (the patient can spontaneously remember the intraoperative event) is very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness of intraoperative events may occur in approximately 37% of patients in experimental studies (as identified by the validated clinical procedure the isolated forearm test that does not require postoperative recall of the event). In this international cohort study, recruiting a minimum sample of 200 patients, the investigators will investigate the incidence of anaesthesia awareness (as identified by the isolated forearm test) following the induction of anaesthesia and before surgery.

Detailed Summary:
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Incidence of isolated forearm test responsiveness following laryngoscopy and intubation [ Time Frame: The test will occur within one minute of securing the airway (laryngoscopy and intubation). ]

Following induction of anaesthesia, and securing the airway (laryngoscopy and intubation) the patient will be asked to squeeze the anaesthetist's hand as a surrogate of awareness under anaesthesia.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of isolated forearm test responsiveness before laryngoscopy and intubation [ Time Frame: The test will occur in the minute prior to securing the airway (laryngoscopy and intubation). ]
    Following induction of anaesthesia, and prior to securing the airway (before laryngoscopy and intubation) if safe to do so, the patient will be asked to squeeze the anaesthetist's hand as a surrogate of anaesthesia awareness.
  • Incidence of anaesthesia awareness with recall [ Time Frame: Within 24 hours of the operation ]
    After the operation and emergence from anaesthesia, and within 24 hours of the operation, the patient will be asked, using the structured Modified Brice questionnaire, about recall of intraoperative events (anaesthesia awareness).
  • Patient satisfaction questionnaire [ Time Frame: Within 24 hours of the operation and emergence from anaesthesia ]
    Within 24 hours of the operation and emergence from anaesthesia, the patient will be asked to complete a patient satisfaction questionnaire rating the anaesthetic care they received. This will cover the preoperative information they were given, their emergence from anaesthesia, their pain control, experience of nausea and vomiting and their general experience. They will be asked to rate their care from four options: very satisfied, satisfied, dissatisfied and very dissatisfied.


Original Secondary Outcome: Same as current

Information By: University of Wisconsin, Madison

Dates:
Date Received: September 2, 2014
Date Started: March 2015
Date Completion:
Last Updated: April 4, 2016
Last Verified: April 2016