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Clinical Trials/NCT05880615
NCT05880615
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country100 target enrollmentMay 2, 2022
ConditionsCardiac Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Disease
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
100
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2022
End Date
August 1, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Number of hypoxemia postoperative in the first 48 hours after extubation(Hours: 48)
  • Total morphine consumption within 48h after extubation(Hours: 48)
  • Pain at 24 hours and 48 hours postoperative(Hours: 24, 48)
  • postoperative nausea and vomiting(Hours: 48)
  • major complications (neurological, respiratory, cardiac, infectious)(Hours: 48)
  • Number of Ileus postoperative in the first 48 hours after extubation(Hours: 48)
  • mortality at 30 days after surgery(Day: 30)

Study Sites (1)

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