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Vasopressor Requirements Depends on Sedation Strategy

Primary Purpose

Sedative Adverse Reaction, Sedation Complication, Hemodynamic Instability

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Dexmedetomidine and Propofol
Sponsored by
Anesthesia Research Group UA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedative Adverse Reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Cardiosurgery departments with intensive care block

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Propofol group

Dexmedetomidine group

Dexmedetomidine and propofol group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay in the ICU
measure at days

Full Information

First Posted
June 21, 2022
Last Updated
July 8, 2022
Sponsor
Anesthesia Research Group UA
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1. Study Identification

Unique Protocol Identification Number
NCT05451381
Brief Title
Vasopressor Requirements Depends on Sedation Strategy
Official Title
Vasopressor Requirements During Dexmedetomidine Sedation vs Propofol vs Their Combination (Dexmedetomidine and Propofol) Sedation in Patients After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anesthesia Research Group UA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedative Adverse Reaction, Sedation Complication, Hemodynamic Instability, Agitation on Recovery From Sedation, Respiratory Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Experimental
Arm Description
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
Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
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
Arm Title
Dexmedetomidine and propofol group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
PR
Intervention Description
sedation after cardiac surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DEX
Intervention Description
sedation after cardiac surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine and Propofol
Other Intervention Name(s)
DEX+PR
Intervention Description
sedation after cardiac surgery
Primary Outcome Measure Information:
Title
vasopressor requirements
Description
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)
Title
dose of norepinephrine
Description
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 Outcome Measure Information:
Title
Length of stay in the ICU
Description
measure at days
Time Frame
before discharging from ICU to the ward ( up to 3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelyzaveta Plechysta, MD
Organizational Affiliation
Chief of the anesthesia department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiosurgery departments with intensive care block
City
Kyiv
ZIP/Postal Code
01000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

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Vasopressor Requirements Depends on Sedation Strategy

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