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

Cardiac Disease Clinical Trial

— ORACAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05880615
• Other study ID #: IRBN452022/CHUSTE
• Status: Completed
• Start date: May 2, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Delirium
• Emergence Delirium
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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