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

Completed

• Conditions: Cardiac Disease
• Interventions: Other: collection of datas

• Registration Number: NCT05880615
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2022-05-02
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Opioid Anesthesia (OA)	collection of datas	Patients with Opioid Anesthesia (OA) will be included.
opioid reduced anesthesia with parasternal catheters inserted before sternotomy	collection of datas	Patients with opioid reduced anesthesia with parasternal catheters inserted before sternotomy will be included.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total morphine consumption within 48h after extubation	Hours: 48	Data collected in medical record
Number of hypoxemia postoperative in the first 48 hours after extubation	Hours: 48	Data collected in medical record: PaO2/FiO2 \< 300
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.
Number of Ileus postoperative in the first 48 hours after extubation	Hours: 48	Data collected in medical record:absence of gas and/or material
mortality at 30 days after surgery	Day: 30	Data collected in medical record.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France