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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
Sponsor:
Collaborators:
University of Groningen
Centre Hospitalier Régional de la Citadelle
RWTH Aachen University
University of Auckland, New Zealand
University of Michigan
University of Witten/Herdecke
University College London Hospitals
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.

Condition or disease
Anaesthesia

Study Design
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Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing anaesthesia requiring intubation and layngoscopy
Criteria

Inclusion Criteria:

  • Adult patients clinically requiring intubation will be included in this cohort.
  • Patients must be able to follow the isolated forearm technique commands when awake and prior to their operation will be included in this cohort.

Exclusion Criteria:

  • Contraindication to isolated forearm technique test such as unable to have tourniquet on arm for the isolated forearm technique (e.g. lymphedema or operative site).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States
New Zealand
University of Auckland
Hamilton, Waikato, New Zealand
Sponsors and Collaborators
University of Wisconsin, Madison
University of Groningen
Centre Hospitalier Régional de la Citadelle
RWTH Aachen University
University of Auckland, New Zealand
University of Michigan
University of Witten/Herdecke
University College London Hospitals
Investigators
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Principal Investigator: Robert D Sanders, MBBS PhD FRCA University of Wisconsin, Madison
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02248623    
Other Study ID Numbers: ConsCIOUS
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by University of Wisconsin, Madison:
Anaesthesia
Isolated forearm test
Responsiveness
Laryngoscopy
Intubation
Additional relevant MeSH terms:
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Intraoperative Awareness
Intraoperative Complications
Pathologic Processes