Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

NCT ID: NCT02248623

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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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 Description

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Conditions

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Anaesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Groningen

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role collaborator

University of Auckland, New Zealand

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert D Sanders, MBBS PhD FRCA

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

University of Auckland

Hamilton, Waikato Region, New Zealand

Site Status

Countries

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United States New Zealand

References

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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.

Reference Type DERIVED
PMID: 29121278 (View on PubMed)

Other Identifiers

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ConsCIOUS

Identifier Type: -

Identifier Source: org_study_id

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