Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia (ConsCIOUS)
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|ClinicalTrials.gov Identifier: NCT02248623|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : April 6, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||260 participants|
|Official Title:||An International Multi-Centre Cohort Study of the Incidence of Anaesthesia Awareness Following Laryngoscopy and Intubation: The CONSciousness, Connectedness and IntraOperative Unresponsiveness Study (ConsCIOUS)|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2015|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248623
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States|
|University of Auckland|
|Hamilton, Waikato, New Zealand|
|Principal Investigator:||Robert D Sanders, MBBS PhD FRCA||University of Wisconsin, Madison|