We propose a prospective cohort study to identify the incidence of responsiveness as a surrogate of anesthesia awareness following laryngoscopy in standard clinical practice.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anesthesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•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 outcome
•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.
Background 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.
Study objective
We propose a prospective cohort study to identify the incidence of
responsiveness as a surrogate of anesthesia awareness following laryngoscopy in
standard clinical practice.
Study design
Observational Model: Cohort
Time Perspective: Prospective
Study burden and risks
Risks associated with blood pressure cuff placement
There is a risk that placement of an additional blood pressure cuff may cause
additional discomfort including pain and paresthesia (tingling); however, the
subject will be clinically anesthetized with good pain relief administered.
Other problems such as ischemic paralysis are not anticipated due to the
relatively short exposure of the tourniquet. This risk is minimal as the blood
pressure cuff will only be inflated to 50 mm Hg above systolic pressure for a
maximum of 15 minutes and only while clinically indicated. Similar tourniquets
are commonly inflated to 100mmHg above systolic pressure and used for up to 90
minutes during surgery and so we anticipate minimal risk from this much shorter
duration of exposure.
Unknown risks
This study may involve risks to the subject which are currently unforeseeable.
We will inform subjects as soon as possible if we discover any information that
may affect the subject's health, welfare, or decision to be in this study
hanzeplein 1
groningen 9713 EZ
NL
hanzeplein 1
groningen 9713 EZ
NL
Listed location countries
Age
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
1. Age < 18 years old
2. Unable or unwilling to sign consent
3. Unable to undergo postoperative questions
4. Contraindication to IFT test such as unable to have tourniquet on arm for the IFT (e.g. lymphedema or operative site), rapid sequence inductions and requiring paralysis for laryngoscopy and intubation, per discretion of the PI.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52381.042.15 |
| Other | ntc02248623 |