Clinical trial NCT02248623: Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaesthesia
Keywords: Anaesthesia
Isolated forearm test
Responsiveness
Laryngoscopy
Intubation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Groningen
name: Centre Hospitalier Régional de la Citadelle
name: RWTH Aachen University
name: University of Auckland, New Zealand
name: University of Michigan
name: University of Witten/Herdecke
name: University College London Hospitals
First posted: 2014-09-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing anaesthesia requiring intubation and layngoscopy

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.


Eligibility 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).

Primary outcomes:
measure: Incidence of isolated forearm test responsiveness following laryngoscopy and intubation
timeFrame: The test will occur within one minute of securing the airway (laryngoscopy and intubation).
Secondary outcomes:
measure: Incidence of isolated forearm test responsiveness before laryngoscopy and intubation
timeFrame: The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).
measure: Incidence of anaesthesia awareness with recall
timeFrame: Within 24 hours of the operation
measure: Patient satisfaction questionnaire
timeFrame: Within 24 hours of the operation and emergence from anaesthesia
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Hamilton
country: New Zealand
facility: University of Auckland
state: Waikato
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert D Sanders, MBBS PhD FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.