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CompletedNCT05451381Updated Jul 12, 2022

Vasopressor Requirements Depends on Sedation Strategy

An interventional study of Propofol and Dexmedetomidine in Sedative Adverse Reaction, Sedation Complication and Hemodynamic Instability, sponsored by Anesthesia Research Group UA. Completed at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Anesthesia Research Group UA · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Aug 2017, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.

Read the detailed description

Sedating a patient is a complex process, especially after heart surgery. Sedation has a negative hemodynamic effect. This leads to a decrease in blood pressure and increases the frequency and dose of vasopressors used. The choice of drug for sedation may have an impact on reducing the frequency of use of vasopressor therapy. The goal of the research is compare three strategies: propofol ( sedative agent), dexmedetomidine ( selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative effect) and their combination for sedation after cardiac surgery.

02

Conditions studied

  • Sedative Adverse Reaction
  • Sedation Complication
  • Hemodynamic Instability
  • Agitation on Recovery From Sedation
  • Respiratory Complication

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03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 356 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

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Lead sponsor

Anesthesia Research Group UA is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • Age of patients from 18-80 years;
  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    Propofol group

    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

    Drug: Propofol

  • Experimental
    Dexmedetomidine group

    Patient sedation after cardiac surgery at the intensive care unit. Sedation group Dexmedetomidine (DEX): continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h

    Drug: Dexmedetomidine

  • Experimental
    Dexmedetomidine and propofol group

    Patient sedation after cardiac surgery at the intensive care unit. Sedation group DEX+PR: 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

    Drug: Dexmedetomidine and Propofol

Interventions

  • DrugPropofol

    sedation after cardiac surgery

    Also known as: PR

  • DrugDexmedetomidine

    sedation after cardiac surgery

    Also known as: DEX

  • DrugDexmedetomidine and Propofol

    sedation after cardiac surgery

    Also known as: DEX+PR

06

What researchers measure

Primary outcomes

  1. vasopressor requirements

    incidence of cases of using norepinephrine. measurement tool is a fact of using that is marked as yes\\no in the check-list

    Time frame: every hour during sedation(up to 12 hours)

  2. dose of norepinephrine

    measure the maximum dose of norepinephrine in mcg\\kg\\min to achieve mean arterial pressure 70 mmHg

    Time frame: every hour during sedation (up to 12 hours)

Secondary outcomes

  1. Length of stay in the ICU

    measure at days

    Time frame: before discharging from ICU to the ward ( up to 3 days)

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Study locations

1 site
  • Cardiosurgery departments with intensive care block
    Kyiv, 01000, Ukraine
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05451381
Lead sponsor
Anesthesia Research Group UA
Responsible party
Plechysta Yelyzaveta (chief of the anesthesia department, Anesthesia Research Group UA) — Principal investigator
First posted
Jul 11, 2022
Start date
Aug 1, 2017
Primary completion
May 1, 2022
Completion
May 29, 2022
Last update
Jul 12, 2022

Study contacts

Yelyzaveta Plechysta, MD
principal investigator · Chief of the anesthesia department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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