Cardiac DiseaseORACATNCT05880615
Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery
An observational study of Cardiac Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- collection of datas
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2022to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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%
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study investigate the effect of an enhanced recovery protocol using regional anesthesia on PostOperative Delirium (POD) onset.
- Conditions
- Cardiac Disease
- Being tested
- collection of datas
- Keywords
- Cardiac surgery, postoperative delirium, regional anesthesia, enhanced recovery after surgery
- Medical subject headings
- Heart Diseases, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of datasOther
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
| Study group | Role | What they receive |
|---|---|---|
| opioid reduced anesthesia with parasternal catheters inserted before sternotomy | Patients with opioid reduced anesthesia with parasternal catheters inserted before sternotomy will be included. Receives: Other: collection of datas | |
| Opioid Anesthesia (OA) | Patients with Opioid Anesthesia (OA) will be included. Receives: Other: collection of datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hours: 48
Secondary outcomes (7)
Number of hypoxemia postoperative in the first 48 hours after extubation
Data collected in medical record: PaO2/FiO2 < 300
Measured: Hours: 48
Number of Ileus postoperative in the first 48 hours after extubation
Data collected in medical record:absence of gas and/or material
Measured: Hours: 48
Total morphine consumption within 48h after extubation
Data collected in medical record
Measured: Hours: 48
Pain at 24 hours and 48 hours postoperative
Data collected in medical record
Measured: Hours: 24, 48
postoperative nausea and vomiting
Data collected in medical record.
Measured: Hours: 48
major complications (neurological, respiratory, cardiac, infectious)
Data collected in medical record.
Measured: Hours: 48
mortality at 30 days after surgery
Data collected in medical record.
Measured: Day: 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start2 May 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie GRAND, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880615
- Sponsor's protocol ID
- IRBN452022/CHUSTE
- Acronym
- ORACAT
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05880615
- Acronym / sponsor ID
- ORACAT / IRBN452022/CHUSTE
- Conditions
- Cardiac Disease
- Keywords
- Cardiac surgery, postoperative delirium, regional anesthesia, enhanced recovery after surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid reduced anesthesia with parasternal catheters inserted before sternotomy | – | Other: collection of datasPatients with opioid reduced anesthesia with parasternal catheters inserted before sternotomy will be included. |
| Opioid Anesthesia (OA) | – | Other: collection of datasPatients with Opioid Anesthesia (OA) will be included. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of datascollection 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 | Other | Opioid Anesthesia (OA), opioid reduced anesthesia with parasternal catheters inserted before sternotomy |
Primary outcome
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.
7 secondary outcomes
Number of hypoxemia postoperative in the first 48 hours after extubation
Time frame: Hours: 48
Number of Ileus postoperative in the first 48 hours after extubation
Time frame: Hours: 48
Total morphine consumption within 48h after extubation
Time frame: Hours: 48
Pain at 24 hours and 48 hours postoperative
Time frame: Hours: 24, 48
postoperative nausea and vomiting
Time frame: Hours: 48
major complications (neurological, respiratory, cardiac, infectious)
Time frame: Hours: 48
mortality at 30 days after surgery
Time frame: Day: 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie GRAND, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.