CLINICAL TRIAL

Treatment for Postoperative Cognitive Complications

Recruiting · 65+ · All Sexes · San Francisco, CA

Effects of Brain Beta-Amyloid on Postoperative Cognition

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About the trial for Postoperative Cognitive Complications

Eligible Conditions
Cognitive Dysfunction · Postoperative Cognitive Complications · POCD - Postoperative Cognitive Dysfunction

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Scheduled for total knee arthroplasty or total hip arthroplasty under general anesthesia (primary arthroplasties and revisions)
Anticipated stay in the hospital
Not anticipated to stay intubated postoperatively
Patients who live with or have regular visits from an individual ("study partner") willing to provide information about the patient's cognitive status
Willing and able to undergo all testing procedures including neuroimaging and agree to longitudinal follow up
Adequate visual and auditory acuity to allow neuropsychological testing
Subjects with Clinical Dementia Rating Scale (CDR) of 0-0.5
Patients who are not demented
Subjects sho signed an IRB approved informed consent prior to any study procedures
English speaking
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Participants will be followed from preoperative baseline to 1 year postoperative
Screening: ~3 weeks
Treatment: Varies
Reporting: Participants will be followed from preoperative baseline to 1 year postoperative
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Participants will be followed from preoperative baseline to 1 year postoperative.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 14 secondary outcomes in patients with Postoperative Cognitive Complications. Measurement will happen over the course of Participants will be followed for the duration of hospital stay, an expected average of 1 week.

Hospital Length of Stay
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Measured using patient medical records
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Coma Assessment
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Measured using the Richmond Agitation Sedation Scale (RASS)
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Perioperative Complications
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Measured using patient medical records
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Delirium
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit
PARTICIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AN EXPECTED AVERAGE OF 1 WEEK
Cognitive Decline
AT THE TIME OF DISCHARGE (OR AT THE LATEST ON THE 7TH POSTOPERATIVE DAY)
Measured using comprehensive neurocognitive test battery
AT THE TIME OF DISCHARGE (OR AT THE LATEST ON THE 7TH POSTOPERATIVE DAY)
Inflammatory Markers
PARTICIPANTS WILL BE FOLLOWED FROM PREOPERATIVE BASELINE TO 1 YEAR POSTOPERATIVE
Measured by obtaining blood samples
PARTICIPANTS WILL BE FOLLOWED FROM PREOPERATIVE BASELINE TO 1 YEAR POSTOPERATIVE
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does postoperative cognitive complications run in families?

Cognitive recovery after general anesthesia is affected by many factors including age, gender, anesthetic technique, and duration of surgery. For reasons currently unknown, this phenomenon is best explained by cognitive heterogeneity.

Anonymous Patient Answer

What are the signs of postoperative cognitive complications?

Cognitive complications after surgery may be associated with an increased risk of postoperative depressive symptoms, confusion, and a shorter LOS in the hospital. These data also highlight the potential need for proactive screening, timely interventions, and early referral for medical therapy when symptomatic.

Anonymous Patient Answer

What causes postoperative cognitive complications?

We did not find an association between postoperative cognitive complication and patient sex, age, ASA (American Society of Anesthesiologists) score at surgery and dementia after surgery. The major cause of postoperative psychiatric morbidity among patients who required re-admission for psychiatric disorders was a high baseline burden of mental health and psychiatric problems and chronic alcoholism.

Anonymous Patient Answer

Can postoperative cognitive complications be cured?

POCD is highly prevalent after cardiac surgery and the risk of POCD increased in patients who had a low socioeconomic status. Surgical techniques, including neurocognitive assessments, could be useful to identify patients at high risk of POCD.

Anonymous Patient Answer

What are common treatments for postoperative cognitive complications?

These data suggest that the majority of doctors do not use one of the recommended treatments listed herein for patients who suffer from postoperative cognitive complications. However, this may be due to difficulty in diagnosing and managing such patients. A few specialists have a good tendency to use these drugs, but not as frequently as other specialists. More doctors would be interested in learning these medications and methods and using them after seeing the patient. The use of different drugs and methods may be a good option to help those who suffer from postoperative cognitive complications.

Anonymous Patient Answer

What is postoperative cognitive complications?

The data indicate that POCCs, when present, are more common in patients who undergo non-elective cranial or spinal surgery versus non-elective procedures such as hernia surgery, and that the likelihood of occurrence is increased for surgical operations involving the posterior cranial fossa such as skull base and cerebellar procedures.

Anonymous Patient Answer

How many people get postoperative cognitive complications a year in the United States?

An increasing number of neuropsychiatric diagnoses occur in the first 14 postoperative days. Some research suggests this could be related to either procedural and/or perioperative pain.

Anonymous Patient Answer

Does treatment improve quality of life for those with postoperative cognitive complications?

Postoperative cognitive complications (POCD) negatively affect quality of life. Treatment is safe, effective, and can be performed at the bedside or outpatient setting. POCD can be improved by cognitive therapy or antidepressant treatment.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Despite the availability of studies demonstrating superiority of treatment over controls, no studies have reported the use of pharmacological treatments as treatment instead of a placebo in order to prove the superiority. A systematic review indicated that 'despite its limitations, the current findings do provide some support for pharmacological treatment to be beneficial. There is, however, little evidence that pharmacological intervention is more effective than a placebo'. In future studies, using pharmacological treatments and a placebo combined with a clinical assessment should be considered for assessing efficacy of pharmacological treatments.

Anonymous Patient Answer

What does treatment usually treat?

[Only 20% of patients report being well-informed about their treatment options] Most patients reported being well informed about the treatment options available. There is no evidence that receiving information before surgery enhances post-operative recovery (PSA: 5.9 ± 2.8 vs. 4.9 ± 2.0; p = 0.07; VAS: 15.8 ± 7.9 vs. 16.5 ± 14.3; p = 0.90). More than half the patients (54%) reported receiving information from their multidisciplinary clinician, including information on post-operative complications. Patients reported receiving information from their clinician in the preceding 6 months had longer post-operative hospital recovery times (7.

Anonymous Patient Answer

What is the primary cause of postoperative cognitive complications?

A large proportion of patients undergoing abdominal hysterectomy will be screened for PCE in the days after surgery. This might help us identify specific patients at a higher risk of developing PCE, so that clinicians will be able to address some of the concerns related to the development of this complication in the postoperative period prior to surgery and therefore improve compliance with postoperative safety measures. Nevertheless, the primary cause of PCE is not fully understood.

Anonymous Patient Answer

Have there been any new discoveries for treating postoperative cognitive complications?

A wide range of techniques have been investigated for alleviating these complications, yet it is not clear which might be the most effective when compared to the others. There is no evidence supporting or casting doubt on the efficacy of any one treatment technique.

Anonymous Patient Answer
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