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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT05880615

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Other: collection of datas

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 2, 2022

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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) Patients with Opioid Anesthesia (OA) will be included.	Other: collection of datas 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

Arm

Intervention/Treatment

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

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)

Patients with Opioid Anesthesia (OA) will be included.

Other: collection of datas

Outcome Measures

Primary Outcome Measures

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 [Hours: 48]
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.

Secondary Outcome Measures

Number of hypoxemia postoperative in the first 48 hours after extubation [Hours: 48]
Data collected in medical record: PaO2/FiO2 < 300
Number of Ileus postoperative in the first 48 hours after extubation [Hours: 48]
Data collected in medical record:absence of gas and/or material
Total morphine consumption within 48h after extubation [Hours: 48]
Data collected in medical record
Pain at 24 hours and 48 hours postoperative [Hours: 24, 48]
Data collected in medical record
postoperative nausea and vomiting [Hours: 48]
Data collected in medical record.
major complications (neurological, respiratory, cardiac, infectious) [Hours: 48]
Data collected in medical record.
mortality at 30 days after surgery [Day: 30]
Data collected in medical record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients were enrolled over 18 admitted 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 and allergy to locals anesthesics or any drugs