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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02248623
Registration number
NCT02248623
Ethics application status
Date submitted
2/09/2014
Date registered
25/09/2014
Date last updated
6/04/2016
Titles & IDs
Public title
Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia
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Scientific 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)
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Secondary ID [1]
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ConsCIOUS
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Universal Trial Number (UTN)
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Trial acronym
ConsCIOUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaesthesia
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Condition category
Condition code
Surgery
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Other surgery
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Anaesthesiology
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of isolated forearm test responsiveness following laryngoscopy and intubation
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Assessment method [1]
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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.
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Timepoint [1]
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The test will occur within one minute of securing the airway (laryngoscopy and intubation).
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Secondary outcome [1]
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Incidence of isolated forearm test responsiveness before laryngoscopy and intubation
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Assessment method [1]
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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.
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Timepoint [1]
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The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).
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Secondary outcome [2]
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Incidence of anaesthesia awareness with recall
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Assessment method [2]
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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).
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Timepoint [2]
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Within 24 hours of the operation
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Secondary outcome [3]
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Patient satisfaction questionnaire
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Assessment method [3]
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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.
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Timepoint [3]
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Within 24 hours of the operation and emergence from anaesthesia
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2015
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Sample size
Target
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Accrual to date
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Final
260
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Michigan
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Country [2]
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United States of America
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State/province [2]
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Wisconsin
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Country [3]
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New Zealand
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State/province [3]
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Waikato
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Wisconsin, Madison
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Groningen
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Centre Hospitalier Régional de la Citadelle
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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RWTH Aachen University
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Auckland, New Zealand
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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University of Michigan
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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University of Witten/Herdecke
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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University College London Hospitals
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Address [7]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02248623
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Trial related presentations / publications
Gaskell AL, Hight DF, Winders J, Tran G, Defresne A, Bonhomme V, Raz A, Sleigh JW, Sanders RD. Frontal alpha-delta EEG does not preclude volitional response during anaesthesia: prospective cohort study of the isolated forearm technique. Br J Anaesth. 2017 Oct 1;119(4):664-673. doi: 10.1093/bja/aex170.
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Public notes
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Contacts
Principal investigator
Name
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Robert D Sanders, MBBS PhD FRCA
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Address
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University of Wisconsin, Madison
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02248623
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