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Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

An International Multi-Centre Cohort Study of the Incidence of Anaesthesia Awareness Following Laryngoscopy and Intubation: The CONSciousness, Connectedness and IntraOperative Unresponsiveness Study (ConsCIOUS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02248623
Acronym
ConsCIOUS
Enrollment
260
Registered
2014-09-25
Start date
2015-03-31
Completion date
2015-10-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

Anaesthesia, Isolated forearm test, Responsiveness, Laryngoscopy, Intubation

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.

Interventions

None listed

Sponsors

University of Groningen
CollaboratorOTHER
Centre Hospitalier Régional de la Citadelle
CollaboratorOTHER
RWTH Aachen University
CollaboratorOTHER
University of Auckland, New Zealand
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
University of Witten/Herdecke
CollaboratorOTHER
University College London Hospitals
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Incidence of isolated forearm test responsiveness following laryngoscopy and intubationThe 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

MeasureTime frameDescription
Incidence of isolated forearm test responsiveness before laryngoscopy and intubationThe 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 recallWithin 24 hours of the operationAfter 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 questionnaireWithin 24 hours of the operation and emergence from anaesthesiaWithin 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.

Countries

New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026