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An International Multi-Center Cohort Study of the Incidence of Anesthesia Awareness Following Laryngoscopy and Intubation

An International Multi-Center Cohort Study of the Incidence of Anesthesia Awareness Following Laryngoscopy and Intubation - Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42193
Enrollment
25
Registered
2015-08-17
Start date
2015-08-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anesthesie Intraoperative Awareness Intraoperative Complications

Interventions

None listed

Sponsors

anesthesiologie- onderzoeksbureau
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old 2. English competent 3. Informed consent obtained 4. Patients clinically requiring general anesthesia and intubation 5. Only patients able to safely follow the IFT commands when awake and prior to their operation, per discretion of the PI.

Exclusion criteria

Exclusion criteria: 1. Age

Design outcomes

Primary

MeasureTime frame
•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). ] [ Designated as safety issue: No ] 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

MeasureTime frame
•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). ] [ Designated as safety issue: No ] 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 [ Time Frame: Within 24 hours of the operation ] [ Designated as safety issue: No ] 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 [ Time Frame: Within 24 hours of the operation and emergence from anaesthesia ] [ Designated as safety issue: No ] 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)