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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05880615
Acronym
ORACAT
Enrollment
100
Registered
2023-05-30
Start date
2022-05-02
Completion date
2022-08-01
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

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

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.

Interventions

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Postoperative delirium (POD) assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in the first 48 hours after surgeryHours: 48assessed 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.

Secondary

MeasureTime frameDescription
Number of Ileus postoperative in the first 48 hours after extubationHours: 48Data collected in medical record:absence of gas and/or material
Total morphine consumption within 48h after extubationHours: 48Data collected in medical record
Pain at 24 hours and 48 hours postoperativeHours: 24, 48Data collected in medical record
Number of hypoxemia postoperative in the first 48 hours after extubationHours: 48Data collected in medical record: PaO2/FiO2 \< 300
major complications (neurological, respiratory, cardiac, infectious)Hours: 48Data collected in medical record.
mortality at 30 days after surgeryDay: 30Data collected in medical record.
postoperative nausea and vomitingHours: 48Data collected in medical record.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026