Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

NCT02248623 | Completed DMC

• 1 other identifier: ConsCIOUS
• Study Type: observational
• Target: 260
• Locations: 2 countries
• Sites: 3

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.

Conditions

Anaesthesia

Keywords

Anaesthesia; Isolated forearm test; Responsiveness; Laryngoscopy; Intubation

Outcome Measures

Primary Outcomes (1)

• Incidence of isolated forearm test responsiveness following 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.

  The test will occur within one minute of securing the airway (laryngoscopy and intubation).

Secondary Outcomes (3)

• Incidence of isolated forearm test responsiveness before laryngoscopy and intubation

  The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).

• Incidence of anaesthesia awareness with recall

  Within 24 hours of the operation

• Patient satisfaction questionnaire

  Within 24 hours of the operation and emergence from anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing anaesthesia requiring intubation and layngoscopy

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, United States

Location

University of Wisconsin

Madison, Wisconsin, United States

Location

University of Auckland

Hamilton, Waikato Region, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 29121278 DERIVED

Study Officials

• Robert D Sanders, MBBS PhD FRCA

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 25, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

US (2); NZ (1)