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

NCT ID: NCT05880615

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2022-08-01

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.

Conditions

Cardiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

opioid reduced anesthesia with parasternal catheters inserted before sternotomy

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

collection of datas

Intervention Type: 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)

Patients with Opioid Anesthesia (OA) will be included.

collection of datas

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie GRAND, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

IRBN452022/CHUSTE

Identifier Type: -

Identifier Source: org_study_id