Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention

NCT05877326 | Unknown DMC

• 1 other identifier: 2022-A02200-43
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To demonstrate the benefit of reduced depth of anesthesia

  The presence of mental confusion using CAM-ICU ( The Confusion Assessment Method for the Intensive Care Unit )

  Day 3 post intervention.

Study Arms (2)

Perioperative anesthesia with a BIS target of 35

ACTIVE COMPARATOR

Anesthesia with a BIS target of 35

Drug: General anesthesia with propofol or sevoflurane; Behavioral: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative

Perioperative anesthesia with a BIS target of 55

ACTIVE COMPARATOR

Anesthesia with a BIS target of 55

Drug: General anesthesia with propofol or sevoflurane; Behavioral: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative

Interventions

General anesthesia with propofol or sevoflurane DRUG

General anesthesia

Also known as: General anesthesia with 35 BIS target or 55 BIS target

Perioperative anesthesia with a BIS target of 35; Perioperative anesthesia with a BIS target of 55

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

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

Perioperative anesthesia with a BIS target of 35; Perioperative anesthesia with a BIS target of 55

Eligibility Criteria

• Age: 75 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient aged between 75 and 85 years, who signed an informed consent, undergoing elective valvular, coronary artery bypass, aortic or combined cardiac surgery
• Be affiliated to French Health Insurance

You may not qualify if:

• Refusal of consent -Patient unable to read, write or understand French
• Vulnerable patient according to article L1121-6 of the CSP,
• Patient of legal age under guardianship or curatorship or under legal protection,
• Patient unable to give personal consent according to article L.1121-8 of the CSP or adult protected by law,
• Patient having already participated in the present study

Sponsors & Collaborators

• Centre Cardiologique du Nord: lead

Study Sites (1)

Centre cardiologique du nord

Saint-Denis, 93200, France

Location

Related Publications (1)

• Ellouze O, Zogheib E, Abdelhafidh K, Lemaire A, Berger J, Charfeddine A, Bouzguenda H, Konstantinou M, Molinari N, Bonnet N, Geri G, Nappi F. Anaesthetic depth and short-term delirium after cardiac surgery intervention: the study protocol of the BISCAR multicentre randomised clinical trial. BMJ Open. 2025 Aug 28;15(8):e103105. doi: 10.1136/bmjopen-2025-103105.

  PMID: 40876878 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Anesthesia, General; Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Ellouze Omar, MD

  Centre Cardiologique du Nord

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellouze Omar, MD

CONTACT

0149337245; ellouze.omar@yahoo.fr

Moussouni karima, CRA

CONTACT

0679145144; K.MOUSSOUNI@CCN.FR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, controlled, randomized, two parallel-arm trial: Perioperative anesthesia with a BIS target of 35 Perioperative anesthesia with a 55% BIS target

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 26, 2023
• Study Start: September 1, 2023
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)