Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

Completed

• Conditions: Anaesthesia

• Registration Number: NCT02248623
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-25
• Study Start: 2015-03
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of isolated forearm test responsiveness following laryngoscopy and intubation	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 Outcome Measures

Name	Time	Method
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).	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 recall	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).
Patient satisfaction questionnaire	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.

Trial Locations

Locations (3)

University of Auckland; 🇳🇿 Hamilton, Waikato, New Zealand

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States