Sedation ComplicationLOSNCT05809518

Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients Cardiac Surgery

A study testing Propofol injection, Dexmedetomidine injection and Dexmedetomidine and Propofol in people with Sedation Complication, run by Anesthesia Research Group UA at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Preoperative, intraoperative and postoperative management of the patient are some of the main stages that can affect the hospital LOS and ICU LOS. Experience on the evidence-based approach and the progressive guidelines implementation of recommendations, the issue of the choice of drugs for sedation in the family and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sedation Complication
What is being tested?: Propofol injection, Dexmedetomidine injection and Dexmedetomidine and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 194 participants
Where: 1 siteUkraine
Study dates: 1 Jan 2017to 31 Dec 2019
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Multi vascular lesions of the coronary arteries according to coronary angiography;
Heart valve damage was confirmed by heart ultrasound, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
Patient consent to participate in the study;
Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;

Who cannot join

Refusal to participate;
Hypersensitivity to propofol, dexmedetomidine;
Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
Occurred ischemic stroke;
History of the ischemic stroke;
History of the neurodegenerative diseases;

Show all 20Show fewer

History of the mental disorders;
Use of neuroleptics, antidepressants for the last 5 years;
History of the cardiac surgery in the past;
Patients with chronic pulmonary disease (GOLD 3-4)
Patients with asthma (moderate or severe),
Participation in any other clinical trial;
Gastric or duodenal ulcer with risk of bleeding;
Chronic renal failure (ClCr less than 50 ml / h)
Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR> 1.5)
If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
History of the hematological disease;
Alcohol abuse in the anamnesis (3-4 times a week).
Condition after chemotherapy; Pregnancy, lactation.

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

Medical Network Dobrobut
Kyiv, 01000

Other trials in Ukraine

About this study

Official title: Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients After Cardiac Surgery With Cardiac Pulmonary Bypass. Comparison of Propofol-based, Dexmedetomidine-based Sedation or Their Combination.

Read the detailed description

Optimization of sedation regimes can become one of the factors that will help to reduce the length of hospital and ICU stay. The purpose of the study is to track is there a relationship between the drug for sedation and the length of stay of patients in the intensive care unit and in hospital treatment.

Conditions: Sedation Complication
Being tested: Propofol injection, Dexmedetomidine injection, Dexmedetomidine and Propofol
Keywords: cardiac surgery, ICU sedation, hospital LOS, ICU LOS, vasopressors, postoperative sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Propofol injectionDrug
Also called Pr
sedation after cardiac surgery
Dexmedetomidine injectionDrug
Also called Dx
sedation after cardiac surgery
Dexmedetomidine and PropofolDrug
Also called DxPr
sedation after cardiac surgery

Study groups in NCT05809518
Study group	Role	What they receive
Propofol Group	Experimental	Patient sedation after cardiac surgery at the intensive care unit. Sedation group (Pr): continuous infusion of propofol using a syringe pump at the dose of 1-1.5 mg / kg / h Receives: Drug: Propofol injection
Dexmedetomidine group	Experimental	Patient sedation after cardiac surgery at the intensive care unit. Sedation group Dexmedetomidine (Dx): continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h Receives: Drug: Dexmedetomidine injection
Dexmedetomidine and propofol group	Experimental	Patient sedation after cardiac surgery at the intensive care unit. Sedation group DxPr: continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\kg\h Receives: Drug: Dexmedetomidine and Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

hospital LOS
measure at days
Measured: from admission to discharge ( up to 20 days)
ICU LOS
measure at days
Measured: before discharging from ICU to the ward ( up to 7 days)

Secondary outcomes (1)

difference in ICU LOS in patients with vasopressors and without vasopressors
measure at days
Measured: before discharging from ICU to the ward ( up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201731 Dec 2019

First posted12 Apr 2023
Study start1 Jan 2017
Primary completion15 Feb 2018
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedation ComplicationStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05809518
Sponsor's protocol ID: 5-08-039.35
Acronym: LOS
Status last verified: Mar 2023
First submitted: 30 Mar 2023
Last updated: 12 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury

All Sedation Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients After Cardiac Surgery With Cardiac Pulmonary Bypass. Comparison of Propofol-based, Dexmedetomidine-based Sedation or Their Combination.
ClinicalTrials.gov ID: NCT05809518
Acronym / sponsor ID: LOS / 5-08-039.35
Conditions: Sedation Complication
Keywords: cardiac surgery, ICU sedation, hospital LOS, ICU LOS, vasopressors, postoperative sedation
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Anesthesia Research Group UAUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 15 Feb 2018 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 12 Apr 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Propofol Group	Experimental	Drug: Propofol injectionPatient sedation after cardiac surgery at the intensive care unit. Sedation group (Pr): continuous infusion of propofol using a syringe pump at the dose of 1-1.5 mg / kg / h
Dexmedetomidine group	Experimental	Drug: Dexmedetomidine injectionPatient sedation after cardiac surgery at the intensive care unit. Sedation group Dexmedetomidine (Dx): continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h
Dexmedetomidine and propofol group	Experimental	Drug: Dexmedetomidine and PropofolPatient sedation after cardiac surgery at the intensive care unit. Sedation group DxPr: continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\kg\h

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Multi vascular lesions of the coronary arteries according to coronary angiography;
Heart valve damage was confirmed by heart ultrasound, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
Patient consent to participate in the study;
Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;

Key exclusion criteria (20 listed)

Refusal to participate;
Hypersensitivity to propofol, dexmedetomidine;
Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
Occurred ischemic stroke;
History of the ischemic stroke;

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
Propofol injectionAlso: Prsedation after cardiac surgery	Drug	Propofol Group
Dexmedetomidine injectionAlso: Dxsedation after cardiac surgery	Drug	Dexmedetomidine group
Dexmedetomidine and PropofolAlso: DxPrsedation after cardiac surgery	Drug	Dexmedetomidine and propofol group

Primary outcome

hospital LOS
Time frame: from admission to discharge ( up to 20 days)
measure at days
ICU LOS
Time frame: before discharging from ICU to the ward ( up to 7 days)
measure at days

1 secondary outcome

difference in ICU LOS in patients with vasopressors and without vasopressors
Time frame: before discharging from ICU to the ward ( up to 7 days

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 12 Apr 2023.

Related trials for Sedation Complication

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury

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.

Yelyzaveta Plechysta principal investigator

Chief of the anesthesia department

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Propofol injection, Dexmedetomidine injection and Dexmedetomidine and Propofol in people with Sedation Complication, run by Anesthesia Research Group UA at 1 site in Ukraine.

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 4 inclusion and 20 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 12 Apr 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 Ukraine. 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?

hospital LOS (time frame: from admission to discharge ( up to 20 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05809518.

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 12 Apr 2023.