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

Sponsor

Anesthesia Research Group UA (Other)

Overall Status

Completed

CT.gov ID

NCT05809518

Collaborator

(none)

194

Enrollment

Location

Arms

35.9

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 their impact on the length of stay in the intensive care unit and the length of hospitalization remain unsolved.

Condition or Disease	Intervention/Treatment	Phase
Sedation Complication	Drug: Propofol injection Drug: Dexmedetomidine injection Drug: Dexmedetomidine and Propofol	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Feb 15, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 injection sedation after cardiac surgery Other Names: Pr
Experimental: Dexmedetomidine group 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	Drug: Dexmedetomidine injection sedation after cardiac surgery Other Names: Dx
Experimental: Dexmedetomidine and propofol group 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	Drug: Dexmedetomidine and Propofol sedation after cardiac surgery Other Names: DxPr

Arm

Intervention/Treatment

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 injection

sedation after cardiac surgery

Other Names:

Experimental: Dexmedetomidine group

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

Drug: Dexmedetomidine injection

sedation after cardiac surgery

Other Names:

Experimental: Dexmedetomidine and propofol group

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

Drug: Dexmedetomidine and Propofol

sedation after cardiac surgery

Other Names:

DxPr

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

difference in hospital LOS in patients with vasopressors and without vasopressors [from admission to discharge ( up to 20 days)]
measure at days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)
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.