Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

Anaesthesia Clinical Trial

— ConsCIOUS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248623
• Other study ID #: ConsCIOUS
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: April 4, 2016
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaesthesia
• Intraoperative Awareness

Locations

Country	Name	City	State
New Zealand	University of Auckland	Hamilton	Waikato
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (8)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	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

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	Incidence of isolated forearm test responsiveness before 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.	The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).	No
Secondary	Incidence of anaesthesia awareness with recall	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).	Within 24 hours of the operation	No
Secondary	Patient satisfaction questionnaire	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.	Within 24 hours of the operation and emergence from anaesthesia	No