Elderly ; Moderate Risk SurgeryNCT02698982
Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
A study testing Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA) and moderate risk surgery in people with Elderly ; Moderate Risk Surgery, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly ; Moderate Risk Surgery
- What is being tested?
- Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA) and moderate risk surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- May 2016to Mar 2017
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia
- Patients who provide written informed consent
- patient fluent in french
Who cannot join
- Patients under 70 years of age
- Surgery under locoregional anesthesia or emergent surgery or minor risk surgery
- Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery)
- Patients with arrhythmia and/or atrial fibrillation
- Patients with preoperative delirium or cognitive dysfunction (moca test < 26)
- Patients not fluent in French
- Patients without the capacity to give written informed consent or refusal of consent
- Patients undergoing surgery or included in another protocol within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients
The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.
Read the detailed description
Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated.
The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.
- Conditions
- Elderly ; Moderate Risk Surgery
- Being tested
- Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA), moderate risk surgery
- Keywords
- elderly, postoperative cognitive dysfunction, postoperative delirium, depth of anesthesia, intraoperative blood pressure monitoring
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)Device
moderate risk surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Monitoring | Experimental | Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider. Receives: Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA); Procedure: moderate risk surgery |
| Sham | Sham comparator | Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider Receives: Procedure: moderate risk surgery |
| Control | No intervention | elderly non scheduled for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium detected by the Confusion Assessment Method (CAM)
Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day
Measured: 3 day postoperative
Secondary outcomes (1)
postoperative change in cognitive function detected by a battery of neuropsychological test.
Measured: baseline and 1 week and 3 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly ; Moderate Risk SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Boudart, Erasme University Hospital
- Investigators
- Luc Van Obbergh, MD PhD, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698982
- Sponsor's protocol ID
- P2015/539
- Status last verified
- Dec 2017
- First submitted
- 12 Feb 2016
- Last updated
- 26 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients
- ClinicalTrials.gov ID
- NCT02698982
- Acronym / sponsor ID
- P2015/539
- Conditions
- Elderly ; Moderate Risk Surgery
- Keywords
- elderly, postoperative cognitive dysfunction, postoperative delirium, depth of anesthesia, intraoperative blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Mar 2016 (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 aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.
Detailed description
Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated.
The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monitoring | Experimental | Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA), Procedure: moderate risk surgeryElderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider. |
| Sham | Sham comparator | Procedure: moderate risk surgeryElderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider |
| Control | No intervention | –elderly non scheduled for surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia
- Patients who provide written informed consent
- patient fluent in french
Key exclusion criteria (8 listed)
- Patients under 70 years of age
- Surgery under locoregional anesthesia or emergent surgery or minor risk surgery
- Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery)
- Patients with arrhythmia and/or atrial fibrillation
- Patients with preoperative delirium or cognitive dysfunction (moca test < 26)
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 |
|---|---|---|
| Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA) | Device | Monitoring |
| moderate risk surgery | Procedure or surgery | Monitoring, Sham |
Primary outcome
postoperative delirium detected by the Confusion Assessment Method (CAM)
Time frame: 3 day postoperative
Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day
1 secondary outcome
postoperative change in cognitive function detected by a battery of neuropsychological test.
Time frame: baseline and 1 week and 3 month postoperative
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 26 Dec 2017.
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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.
Luc Van Obbergh, MD PhD study director
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA) and moderate risk surgery in people with Elderly ; Moderate Risk Surgery, run by Erasme University Hospital at 1 site in Belgium.
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 3 inclusion and 8 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 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. Some participants in this study may receive a placebo. 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?
postoperative delirium detected by the Confusion Assessment Method (CAM) (time frame: 3 day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2017.