Clinical trial NCT05880615: Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery
Official title: Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Cardiac surgery
postoperative delirium
regional anesthesia
enhanced recovery after surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Hours: 48
Secondary outcomes:
measure: Number of hypoxemia postoperative in the first 48 hours after extubation
timeFrame: Hours: 48
measure: Number of Ileus postoperative in the first 48 hours after extubation
timeFrame: Hours: 48
measure: Total morphine consumption within 48h after extubation
timeFrame: Hours: 48
measure: Pain at 24 hours and 48 hours postoperative
timeFrame: Hours: 24, 48
measure: postoperative nausea and vomiting
timeFrame: Hours: 48
measure: major complications (neurological, respiratory, cardiac, infectious)
timeFrame: Hours: 48
measure: mortality at 30 days after surgery
timeFrame: Day: 30
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Nathalie GRAND, MD
role: PRINCIPAL_INVESTIGATOR
References: