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

June 13, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Scheduled Cardiac Surgery for Coronary Artery Bypass Grafting or Valvular Sternotomy in Patients Aged 18 to 85 Years will be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hours: 48

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Nathalie GRAND, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN452022/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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