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NCT Number: NCT02248623

Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

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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Key information

Conditions

Anaesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Auckland, Hamilton, Waikato Region, New Zealand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Centre Hospitalier Régional de la Citadelle
  • RWTH Aachen University
  • University College London Hospitals
  • University of Auckland, New Zealand
  • University of Groningen
  • University of Michigan
  • University of Witten/Herdecke

Registry information

Official study 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)

Acronym: ConsCIOUS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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