Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery

NCT05880615 | Completed

• 1 other identifier: IRBN452022/CHUSTE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

PostOperative Delirium (POD) is the most common neuropsychiatric complication following cardiac surgery and may be related to morphine consumption. PostOperative Delirium (POD) prolongs hospital and intensive care unit (ICU) length of stay (LOS) and increases morbidity and mortality. No study has been conducted to demonstrate the effect of regional anesthesia using catheters inserted before sternotomy.

Conditions

Cardiac Disease

Keywords

Cardiac surgery; postoperative delirium; regional anesthesia; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• Number of Postoperative delirium (POD) assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in the first 48 hours after surgery

  assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Delirium is diagnosed when criteria 1 and 2 are positive, as well as criteria 3 or 4.

  Hours: 48

Secondary Outcomes (7)

• Number of hypoxemia postoperative in the first 48 hours after extubation

  Hours: 48

• Number of Ileus postoperative in the first 48 hours after extubation

  Hours: 48

• Total morphine consumption within 48h after extubation

  Hours: 48

• Pain at 24 hours and 48 hours postoperative

  Hours: 24, 48

• postoperative nausea and vomiting

  Hours: 48

Study Arms (2)

opioid reduced anesthesia with parasternal catheters inserted before sternotomy

Patients with opioid reduced anesthesia with parasternal catheters inserted before sternotomy will be included.

Other: collection of datas

Opioid Anesthesia (OA)

Patients with Opioid Anesthesia (OA) will be included.

Other: collection of datas

Interventions

collection of datas OTHER

collection of datas: * Post-operative occurrence (within the first 48 hours after extubation) of post-operative delirium via the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) scale result * Post-operative hypoxemia defined as a PaO2/FiO2 ratio \< 300 in the first 48 hours after extubation * reflex ileus defined as the absence of gas and/or matter in the first 48 hours after extubation, * total morphine consumption in the first 48 hours after surgery * pain at 24 hours and 48 hours after surgery * post-operative nausea and vomiting, major complications (neurological, respiratory, cardiac, infectious) * mortality 30 days after surgery

Opioid Anesthesia (OA); opioid reduced anesthesia with parasternal catheters inserted before sternotomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Scheduled Cardiac Surgery for Coronary Artery Bypass Grafting or Valvular Sternotomy in Patients Aged 18 to 85 Years will be included.

You may qualify if:

• Age over 18
• Admitte for scheduled cardiac surgery with sternotomy under cardiopulmonary bypass (CPB) for coronary artery bypass grafting (CABG), surgical correction of valve disease (aortic, mitral or tricuspid) or combined surgery (coronary artery bypass grafting (CABG) and valve replacement).

You may not qualify if:

• Age over 85,
• emergency surgery or heart transplant,
• body mass index (BMI) more than 40 kg.m-2
• reoperation
• Renal insufficiency with glomerular filtration rate (GFR) less than 30 mL.min-1
• left ventricular ejection fraction less than 30%
• respiratory insufficiency with arterial pressure of oxygen less than 60 mmHg
• hepatic insufficiency with prothrombin rate less than 30% or cirrhosis
• chronic hyperglycemia not controlled
• pregnancy
• cognitive impairment chronic use of opioids or drug addiction
• epilepsy
• guardianship
• allergy to locals anesthesics or any drugs

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Heart Diseases; Emergence Delirium

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; 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

Study Officials

• Nathalie GRAND, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: May 2, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)