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

Centre Hospitalier Universitaire de Saint Etienne100 enrolled

Overview

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.

This study investigate the effect of an enhanced recovery protocol using regional anesthesia on PostOperative Delirium (POD) onset.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Cardiac Disease

Interventions

collection of datasOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Locations (1)

CHU Saint-Etienne

Saint-Etienne, France

Outcomes

Primary Outcomes

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.

Time frame: Hours: 48

Secondary Outcomes

Number of hypoxemia postoperative in the first 48 hours after extubation

Data collected in medical record: PaO2/FiO2 \< 300

Time frame: Hours: 48

Number of Ileus postoperative in the first 48 hours after extubation

Data collected in medical record:absence of gas and/or material

Time frame: Hours: 48

Total morphine consumption within 48h after extubation

Data collected in medical record

Time frame: Hours: 48

Pain at 24 hours and 48 hours postoperative

Data collected in medical record

Time frame: Hours: 24, 48

postoperative nausea and vomiting

Data collected in medical record.

Time frame: Hours: 48

major complications (neurological, respiratory, cardiac, infectious)

Data collected in medical record.

Time frame: Hours: 48

mortality at 30 days after surgery

Data collected in medical record.

Data from ClinicalTrials.gov

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