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Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention

NCT05877326 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-06-13

No results posted yet for this study

Summary

Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years.

The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or institutionalization, and the risk of developing dementia or cognitive impairment . Therefore, prevention of POD is a major goal in the perioperative setting.

The investigator proposes this randomized study to evaluate the interest of a reduced anesthetic depth to prevent short-term cognitive disorders after cardiac surgery in elderly subjects.

Method: Patients over 75 years old scheduled to undergo one of the cardiac surgeries of interest (valvular, coronary bypass, aortic or combined surgery) will be randomized to 2 paralell arms :

* Perioperative anesthesia with a BIS (Bispectral index) target of 35
* Perioperative anesthesia with a BIS(Bispectral index) target of 55

The presence of mental confusion will be determined by CAM-ICU ( Confusion Assessment Method for the ICU ) at day 3 post procedure.

Ancillary study: To assess cognitive status at inclusion, discharge and third post operative month using the MOCA(Montreal Cognitive Assessment ).

Conclusion:The hypothesis of this study is that a lower depth of anesthesia will reduce post operative delirium in the first three days in patients older than 75 years who are planned for valvular, coronary artery bypass, aortic or combined cardiac surgery .

Conditions

  • Post-operative Delirium
  • Anaesthetic Depth

Interventions

DRUG

General anesthesia with propofol or sevoflurane

General anesthesia

BEHAVIORAL

CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative

The presence of mental confusion will be determined by CAM-ICU at J3 post intervention.

Sponsors & Collaborators

  • Centre Cardiologique du Nord

    lead OTHER

Principal Investigators

  • Ellouze Omar, MD · Centre Cardiologique du Nord

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2025-05-10
Completion
2025-05-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05877326 on ClinicalTrials.gov