AnaesthesiaConsCIOUSNCT02248623
Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia
An observational study of Anaesthesia, run by University of Wisconsin, Madison at 3 sites in 2 countries.
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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- How many people
- 260 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing anaesthesia requiring intubation and layngoscopy
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Michigan
Ann Arbor, Michigan
University of Wisconsin
Madison, Wisconsin
About this study
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)
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).
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).
Measured: Within 24 hours of the operation
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.
Measured: Within 24 hours of the operation and emergence from anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen, Centre Hospitalier Régional de la Citadelle, RWTH Aachen University, University of Auckland, New Zealand, University of Michigan, University of Witten/Herdecke, University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Robert D Sanders, MBBS PhD FRCA, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248623
- Sponsor's protocol ID
- ConsCIOUS
- Acronym
- ConsCIOUS
- Status last verified
- Apr 2016
- First submitted
- 2 Sep 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29121278
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02248623
- Acronym / sponsor ID
- ConsCIOUS / ConsCIOUS
- Conditions
- Anaesthesia
- Keywords
- Anaesthesia, Isolated forearm test, Responsiveness, Laryngoscopy, Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Groningen, Centre Hospitalier Régional de la Citadelle, RWTH Aachen University, University of Auckland, New Zealand, University of Michigan, University of Witten/Herdecke, University College London Hospitals
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing anaesthesia requiring intubation and layngoscopy
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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).
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.
3 secondary outcomes
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).
Incidence of anaesthesia awareness with recall
Time frame: Within 24 hours of the operation
Patient satisfaction questionnaire
Time frame: Within 24 hours of the operation and emergence from anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 29121278Gaskell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Sanders, MBBS PhD FRCA principal investigator
University of Wisconsin, Madison
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaesthesia, run by University of Wisconsin, Madison at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.