Explicit Recall of Intra-Operative EventsPhase 4BAG-RECALLNCT00682825
Study Evaluating Whether the Bispectral Index Prevents Patients at Higher Risk From Being Awake During Surgery and Anesthesia
A Phase 4 study testing Bispectral index protocol and End tidal anesthetic gas-guided in people with Explicit Recall of Intra-Operative Events, run by Washington University School of Medicine at 3 sites in 2 countries.
Trial summary
The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Explicit Recall of Intra-Operative Events
- What is being tested?
- Bispectral index protocol and End tidal anesthetic gas-guided
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2008to Dec 2010
- Phase
- Phase 4
- 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
Who may be able to join
- MUST HAVE:
- General Anesthesia with volatile anesthetic
- PATIENT CHARACTERISTICS
- Major Criteria (Must have any 1 of the following:)
- Planned open heart surgery
- Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
Show all 15Show fewer
- EF<40%
- Prior history of awareness (recall)
- History of difficult intubation or anticipated difficult intubation
- ASA IV or V status
- Aortic stenosis
- End stage lung disease
- Marginal exercise tolerance not secondary to musculoskeletal dysfunction
- Pulmonary hypertension
- Daily alcohol consumption
Who cannot join
- Surgical procedure that prevents the use of the BIS (e.g. surgery of forehead)
- Patient positioning prevents use of the BIS
- Surgery with wake-up test.
- Less than 18 years of age
- Vulnerable populations, such as those with dementia and those unable to provide informed consent.
- Stroke with residual neurological deficits
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Chicago
Chicago, Illinois
Washington University
St Louis, Missouri, 63110
About this study
Official title: BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.
Read the detailed description
The incidence of anesthesia awareness (AA) is 0.1-0.2% and may result in post traumatic stress disorders. For some patients, owing to illness, medications, substance misuse or surgery, the risk approaches 1%. The B-AWARE Study by Myles et al. suggested that the bispectral index (BIS) monitor, which reportedly reflects anesthetic depth, may decrease the incidence of AA in higher risk patients by 82%. The American Society of Anesthesiologists has published a practice advisory on AA, which does not recommend the routine use of cerebral function monitors. We propose to test the hypothesis that an anesthetic protocol based on BIS decreases the incidence of AA among higher risk patients compared with an anesthetic protocol based on the end-tidal anesthetic gas (ETAG) concentration. We have completed a randomized, single-blinded prospective feasibility study (The B-Unaware Trial) which enrolled 2000 patients at higher risk for AA. Four patients (0.21%; 95% CI=0.06% to 0.57%) had definite AA, of whom two were in the BIS-guided group and two in the ETAG-guided group. Nine patients (0.46%; 95% CI=0.22% to 0.91%) had definite or possible AA, of whom six were in the BIS-guided group and three in the ETAG-guided group. The BAG RECALL study will be a multi-center, prospective, single-blinded, randomized study enrolling 6000 patients at higher risk for AA. The BAG RECALL study is adequately powered and rigorously designed to answer with a reasonable degree of scientific probability whether BIS guidance results in clinically relevant reduction in anesthesia awareness among higher risk patients undergoing general anesthesia.
At the University of Michigan, a parallel study will be conducted - Michigan Awareness Control Study, MACS (NCT00689091) - enrolling 30,000 patients to assess whether the BIS monitor decreases the likelihood of anesthesia awareness among all patients undergoing general anesthesia, regardless of their risk profile. The investigators of this study and the BAG-RECALL study have collaborated in designing these studies and are pre-specifying that common outcome measures will be examined collaboratively including data from both studies.
- Being tested
- Bispectral index protocol, End tidal anesthetic gas-guided
- Keywords
- Anesthesia, Awareness, Bispectral, BIS, Recall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index protocolBehavioural
Aim to titrate anesthesia to maintain BIS between 40 and 60.
End tidal anesthetic gas-guidedBehavioural
Aim to maintain anesthetic gas between 0.7 and 1.3 MAC equivalents
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bispectral index-guided protocol Receives: Behavioral: Bispectral index protocol |
| 2 | Active comparator | End-tidal anesthetic gas-guided protocol Receives: Behavioral: End tidal anesthetic gas-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of explicit recall of events during the surgical and anesthetic periods.
Measured: Three years
Secondary outcomes (25)
Meta-analysis for anesthesia awareness incorporating higher risk patients from the completed B-Unaware Trial (NCT00281489), the BAG-RECALL Trial, and the Michigan Awareness Control Study (MACS)(NCT00689091).
Measured: Three years
Incidence of post-traumatic stress disorder (PTSD).
Measured: Five years
Association between type of awareness event and PTSD, and whether the PTSD is associated with late reporting (30 days) of awareness.
Measured: 5 years
Types of dreams and their relationship to BIS and ETAG.
Measured: Three years
The relationship between deep hypnotic time, anesthetic dose (MAC), mean arterial pressure, and end tidal carbon dioxide, and early (one-month) and late (one-year) mortality.
Measured: Four years
Relationship between BIS, heart rate and blood pressure.
Measured: Three years
Relationship between BIS and anesthesia dose and concentration.
Measured: Three years
Association between baseline BIS values, patient health and early (one-month) and late (one-year) mortality.
Measured: Four years
Interaction between hemispheric dominance and BIS.
Measured: Three years
Effect of red hair phenotypes on the relationship between ETAG and BIS.
Measured: Three years
Refinement of risk factors for anesthesia awareness.
Measured: Three years
Relationship between rising BIS in the PACU and first memory after surgery.
Measured: Three years
Postoperative delirium.
Measured: Three years
BIS and mixed venous saturation.
Measured: Three years
Induction of anesthesia and hypotension.
Measured: Three years
Incidence of postoperative nausea and vomiting.
Measured: Three years
Incidence of and severity of postoperative pain.
Measured: Three years
Effect of BIS and ETAG protocols on time to open eyes, time to extubation, and time spent in the postoperative recovery unit.
Measured: Three years
Effect of a defasciculating dose of a non-depolarizing muscle relaxant on BIS.
Measured: Three years
The effect of patient temperature on BIS.
Measured: Three years
Incidence of recall of traveling to the OR among patients who receive midazolam in the holding area and whose initial BIS reading in the OR is > 60.
Measured: Three years
Relationship between BIS, ETAG and EEG parameters.
Measured: Three years
Annual assessment of practitioners' abilities to interpret BIS tracings and to identify artefacts.
Measured: Three years
Differences in anesthesia practice among four institutions in the USA and Canada as judged by anesthetic doses and BIS readings.
Measured: Three years
Effect of BIS and ETAG protocols on anesthetic dose administration and on BIS readings.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Explicit Recall of Intra-Operative EventsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Anesthesia Education and Research, American Society of Anesthesiologists, University of Chicago, University of Manitoba, University of Michigan
- Investigators
- Michael S Avidan, MBBCh FCA, Principal investigator, Washington University School of MedicineDavid Glick, MD, Study director, University of ChicagoEric Jacobsohn, MBChB, Study chair, University of ManitobaMichael O'Connor, MD, Study director, University of ChicagoAlex S Evers, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682825
- Sponsor's protocol ID
- 07-1253
- Acronym
- BAG-RECALL
- Status last verified
- Jan 2011
- First submitted
- 16 May 2008
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
PubMed 15172773Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
PubMed 18337600Avidan MS, Palanca BJ, Glick D, Jacobsohn E, Villafranca A, O'Connor M, Mashour GA; BAG-RECALL Study Group. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients. BMC Anesthesiol. 2009 Nov 30;9:8. doi: 10.1186/1471-2253-9-8.
PubMed 19948045Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7.
PubMed 19891771Mashour GA, Esaki RK, Tremper KK, Glick DB, O'Connor M, Avidan MS. A novel classification instrument for intraoperative awareness events. Anesth Analg. 2010 Mar 1;110(3):813-5. doi: 10.1213/ANE.0b013e3181b6267d. Epub 2009 Aug 27.
PubMed 19713251Willingham M, Ben Abdallah A, Gradwohl S, Helsten D, Lin N, Villafranca A, Jacobsohn E, Avidan M, Kaiser H. Association between intraoperative electroencephalographic suppression and postoperative mortality. Br J Anaesth. 2014 Dec;113(6):1001-8. doi: 10.1093/bja/aeu105. Epub 2014 May 22.
PubMed 24852500Whitlock EL, Torres BA, Lin N, Helsten DL, Nadelson MR, Mashour GA, Avidan MS. Postoperative delirium in a substudy of cardiothoracic surgical patients in the BAG-RECALL clinical trial. Anesth Analg. 2014 Apr;118(4):809-17. doi: 10.1213/ANE.0000000000000028.
PubMed 24413548Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.
PubMed 21848460
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
- ClinicalTrials.gov ID
- NCT00682825
- Acronym / sponsor ID
- BAG-RECALL / 07-1253
- Keywords
- Anesthesia, Awareness, Bispectral, BIS, Recall
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Foundation for Anesthesia Education and Research, American Society of Anesthesiologists, University of Chicago, University of Manitoba, University of Michigan
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- First posted
- 22 May 2008 (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.
The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.
Detailed description
The incidence of anesthesia awareness (AA) is 0.1-0.2% and may result in post traumatic stress disorders. For some patients, owing to illness, medications, substance misuse or surgery, the risk approaches 1%. The B-AWARE Study by Myles et al. suggested that the bispectral index (BIS) monitor, which reportedly reflects anesthetic depth, may decrease the incidence of AA in higher risk patients by 82%. The American Society of Anesthesiologists has published a practice advisory on AA, which does not recommend the routine use of cerebral function monitors. We propose to test the hypothesis that an anesthetic protocol based on BIS decreases the incidence of AA among higher risk patients compared with an anesthetic protocol based on the end-tidal anesthetic gas (ETAG) concentration. We have completed a randomized, single-blinded prospective feasibility study (The B-Unaware Trial) which enrolled 2000 patients at higher risk for AA. Four patients (0.21%; 95% CI=0.06% to 0.57%) had definite AA, of whom two were in the BIS-guided group and two in the ETAG-guided group. Nine patients (0.46%; 95% CI=0.22% to 0.91%) had definite or possible AA, of whom six were in the BIS-guided group and three in the ETAG-guided group. The BAG RECALL study will be a multi-center, prospective, single-blinded, randomized study enrolling 6000 patients at higher risk for AA. The BAG RECALL study is adequately powered and rigorously designed to answer with a reasonable degree of scientific probability whether BIS guidance results in clinically relevant reduction in anesthesia awareness among higher risk patients undergoing general anesthesia.
At the University of Michigan, a parallel study will be conducted - Michigan Awareness Control Study, MACS (NCT00689091) - enrolling 30,000 patients to assess whether the BIS monitor decreases the likelihood of anesthesia awareness among all patients undergoing general anesthesia, regardless of their risk profile. The investigators of this study and the BAG-RECALL study have collaborated in designing these studies and are pre-specifying that common outcome measures will be examined collaboratively including data from both studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Bispectral index protocolBispectral index-guided protocol |
| 2 | Active comparator | Behavioral: End tidal anesthetic gas-guidedEnd-tidal anesthetic gas-guided protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- General Anesthesia with volatile anesthetic
- PATIENT CHARACTERISTICS
- Major Criteria (Must have any 1 of the following:)
- Planned open heart surgery
- Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
Key exclusion criteria (7 listed)
- Surgical procedure that prevents the use of the BIS (e.g. surgery of forehead)
- Patient positioning prevents use of the BIS
- Surgery with wake-up test.
- Less than 18 years of age
- Vulnerable populations, such as those with dementia and those unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral index protocolAim to titrate anesthesia to maintain BIS between 40 and 60. | Behavioural | 1 |
| End tidal anesthetic gas-guidedAim to maintain anesthetic gas between 0.7 and 1.3 MAC equivalents | Behavioural | 2 |
Primary outcome
The incidence of explicit recall of events during the surgical and anesthetic periods.
Time frame: Three years
25 secondary outcomes
Meta-analysis for anesthesia awareness incorporating higher risk patients from the completed B-Unaware Trial (NCT00281489), the BAG-RECALL Trial, and the Michigan Awareness Control Study (MACS)(NCT00689091).
Time frame: Three years
Incidence of post-traumatic stress disorder (PTSD).
Time frame: Five years
Association between type of awareness event and PTSD, and whether the PTSD is associated with late reporting (30 days) of awareness.
Time frame: 5 years
Types of dreams and their relationship to BIS and ETAG.
Time frame: Three years
The relationship between deep hypnotic time, anesthetic dose (MAC), mean arterial pressure, and end tidal carbon dioxide, and early (one-month) and late (one-year) mortality.
Time frame: Four years
Relationship between BIS, heart rate and blood pressure.
Time frame: Three years
Relationship between BIS and anesthesia dose and concentration.
Time frame: Three years
Association between baseline BIS values, patient health and early (one-month) and late (one-year) mortality.
Time frame: Four years
Interaction between hemispheric dominance and BIS.
Time frame: Three years
Effect of red hair phenotypes on the relationship between ETAG and BIS.
Time frame: Three years
Refinement of risk factors for anesthesia awareness.
Time frame: Three years
Relationship between rising BIS in the PACU and first memory after surgery.
Time frame: Three years
Postoperative delirium.
Time frame: Three years
BIS and mixed venous saturation.
Time frame: Three years
Induction of anesthesia and hypotension.
Time frame: Three years
Incidence of postoperative nausea and vomiting.
Time frame: Three years
Incidence of and severity of postoperative pain.
Time frame: Three years
Effect of BIS and ETAG protocols on time to open eyes, time to extubation, and time spent in the postoperative recovery unit.
Time frame: Three years
Effect of a defasciculating dose of a non-depolarizing muscle relaxant on BIS.
Time frame: Three years
The effect of patient temperature on BIS.
Time frame: Three years
Incidence of recall of traveling to the OR among patients who receive midazolam in the holding area and whose initial BIS reading in the OR is > 60.
Time frame: Three years
Relationship between BIS, ETAG and EEG parameters.
Time frame: Three years
Annual assessment of practitioners' abilities to interpret BIS tracings and to identify artefacts.
Time frame: Three years
Differences in anesthesia practice among four institutions in the USA and Canada as judged by anesthetic doses and BIS readings.
Time frame: Three years
Effect of BIS and ETAG protocols on anesthetic dose administration and on BIS readings.
Time frame: Three years
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 4 Jan 2011.
- Background: PubMed 15172773Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
- Background: PubMed 18337600Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
- Background: PubMed 19948045Avidan MS, Palanca BJ, Glick D, Jacobsohn E, Villafranca A, O'Connor M, Mashour GA; BAG-RECALL Study Group. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients. BMC Anesthesiol. 2009 Nov 30;9:8. doi: 10.1186/1471-2253-9-8.
- Background: PubMed 19891771Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7.
- Background: PubMed 19713251Mashour GA, Esaki RK, Tremper KK, Glick DB, O'Connor M, Avidan MS. A novel classification instrument for intraoperative awareness events. Anesth Analg. 2010 Mar 1;110(3):813-5. doi: 10.1213/ANE.0b013e3181b6267d. Epub 2009 Aug 27.
- Derived from this study: PubMed 24852500Willingham M, Ben Abdallah A, Gradwohl S, Helsten D, Lin N, Villafranca A, Jacobsohn E, Avidan M, Kaiser H. Association between intraoperative electroencephalographic suppression and postoperative mortality. Br J Anaesth. 2014 Dec;113(6):1001-8. doi: 10.1093/bja/aeu105. Epub 2014 May 22.
- Derived from this study: PubMed 24413548Whitlock EL, Torres BA, Lin N, Helsten DL, Nadelson MR, Mashour GA, Avidan MS. Postoperative delirium in a substudy of cardiothoracic surgical patients in the BAG-RECALL clinical trial. Anesth Analg. 2014 Apr;118(4):809-17. doi: 10.1213/ANE.0000000000000028.
- Derived from this study: PubMed 21848460Avidan MS, Jacobsohn E, Glick D, Burnside BA, Zhang L, Villafranca A, Karl L, Kamal S, Torres B, O'Connor M, Evers AS, Gradwohl S, Lin N, Palanca BJ, Mashour GA; BAG-RECALL Research Group. Prevention of intraoperative awareness in a high-risk surgical population. N Engl J Med. 2011 Aug 18;365(7):591-600. doi: 10.1056/NEJMoa1100403.
- Bispectral Index (BIS) Versus Electronic Alerts in the Prevention of Awareness (MACS)Link provided by the sponsor.
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.
Michael S Avidan, MBBCh FCA principal investigator
Washington University School of Medicine
David Glick, MD study director
University of Chicago
Eric Jacobsohn, MBChB study chair
University of Manitoba
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bispectral index protocol and End tidal anesthetic gas-guided in people with Explicit Recall of Intra-Operative Events, run by Washington University School of Medicine 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 15 inclusion and 7 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 4 Jan 2011. 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, Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of explicit recall of events during the surgical and anesthetic periods. (time frame: Three years). 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 NCT00682825, which also lists 8 linked publications.
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 4 Jan 2011.