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Completed

NCT Number: NCT05880615

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

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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Confusion Delirium Emergence Delirium Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of datas

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

Primary outcomes

  1. 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

  1. Number of hypoxemia postoperative in the first 48 hours after extubation

    Time frame: Hours: 48

    Data collected in medical record: PaO2/FiO2 < 300

  2. 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

  3. Total morphine consumption within 48h after extubation

    Time frame: Hours: 48

    Data collected in medical record

  4. Pain at 24 hours and 48 hours postoperative

    Time frame: Hours: 24, 48

    Data collected in medical record

  5. postoperative nausea and vomiting

    Time frame: Hours: 48

    Data collected in medical record.

  6. major complications (neurological, respiratory, cardiac, infectious)

    Time frame: Hours: 48

    Data collected in medical record.

  7. mortality at 30 days after surgery

    Time frame: Day: 30

    Data collected in medical record.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: ORACAT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 30, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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