Treatment for Kandinsky Syndrome

Phase-Based Estimates
1
Effectiveness
1
Safety
CIUSSS de l'Est de l'Île de Montréal, Montréal, Canada
+2 More
Eligibility
65+
All Sexes
Eligible conditions
Kandinsky Syndrome

Study Summary

Neurocognitive Disorders After Major Surgery in Elderly

See full description

Eligible Conditions

  • Kandinsky Syndrome
  • Disease
  • Neurocognitive Disorders
  • Anaesthesia therapy

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 16 secondary outcomes, and 7 other outcomes in patients with Kandinsky Syndrome. Measurement will happen over the course of Intraoperative.

Day 0
Cognitive Trajectories: Evolution of T-MoCA over time (score /22 without unit)
Postoperative neurocognitive disorder evaluated on verbal fluency (Yes/No); dichotomic result.
Intraoperative
Total Dose of Phenylephrine (unit: mcg)
Total Dose of Remifentanil (unit: mcg)
Total Dose of Sevoflurane (unit: ml)
Total burst suppression duration (unit: minutes)
Total cerebral hypoxemia duration (unit: minutes)
Total hypotension duration (unit: minutes)
Total low BIS values duration (unit: minutes)
Postoperative day 1
Awareness (Yes/no); dichotomic result
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result; among prespecified subgroups of patients
Postoperative day 15
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result.
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result; among prespecified subgroups of patients
Postoperative day 2
Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result.
Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result; among prespecified subgroups of patients
Postoperative day 30
Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result.
Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result; among prespecified subgroups of patients
Postoperative day 7
Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result.
Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result; among prespecified subgroups of patients
Postoperative day 90
Postoperative neurocognitive disorder day 90 (Yes/No); dichotomic result.
Postoperative neurocognitive disorder day 90 (Yes/No); dichotomic result; among prespecified subgroups of patients
Day 1
Postoperative delirium (Yes/No); dichotomic result
Day 1
Risk difference between groups of Postoperative neurocognitive disorder adjusted for prespecified risk factors (no unit)

Trial Safety

Trial Design

2 Treatment Groups

Electroencephalographic (EEG)-guided group

This trial requires 314 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Electroencephalographic (EEG)-guided group
Device
Information provided by the BIS (Medtronic, Canada) monitor will guide the volatile anesthetic administration in the EEG-guided group to maintain a BIS value between 40 and 60, a Suppression Ratio (SR; % of time with suppressed brain electrical activity) at 0% or the closest, a direct EEG display without any suppression time and a spectrogram (DSA or density spectral array) with most of the EEG wave frequency within the Alpha (8-12Hz), Theta (4-8Hz) and Delta (0.5-4Hz) frequencies.
Standard Care (SC) group
Other
In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly intraoperative for reporting.

Who is running the study

Principal Investigator
P. R.
Prof. Philippe Richebe, PhD
Ciusss de L'Est de l'Île de Montréal

Closest Location

CIUSSS de l'Est de l'Île de Montréal - Montréal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients 70 years of age or older
Major gynecologic, abdominal, urologic, thoracic or orthopedic surgery via laparoscopy or laparotomy under general anesthesia - with or without concomitant use of regional or neuraxial anesthesia -
Expected anesthesia time of more than 60 minutes
Seen for assessment by internal medicine and/or anesthesiology at the preoperative clinic (CIEPC)

Patient Q&A Section

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Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Kandinsky Syndrome by sharing your contact details with the study coordinator.