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Analgesic Effect and sleep quality of Intravenous, low-dose, dexmedetomidine infusion in cardiac patients after ultra-fast track endotracheal extubation, A randomized placebo-controlled study

Phase 4
Completed
Conditions
Patients underwent cardiac surgery after ultra-fast track endotracheal extubation.
Registration Number
TCTR20210322007
Lead Sponsor
Siriraj Research Fund, Faculty of medicine Siriraj Hospital Mahidol university
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
48
Inclusion Criteria

1. Patients undergoing cardiac surgery who require a general anesthesia and cardiopulmonary bypass are between 25 and 65 years old.
2. It's a elective case, non-emergency surgery.
3. The cardiac surgery with have the duration of aortic cross-clamp times less than 2 hours, according to affects the abnormal blood clotting process.
4. It is a cardiac surgical composit of repair/replacement of the valve or an interatrial/ interventricular septal defect.
5. Simple CABG, uncomplicated combined surgery, uncomplicated redo surgery.

Exclusion Criteria

1. Patients with extracorporeal membrane oxygenation (ECMO) or patients with poor LVEF who need to support their heart function with intra-aortic balloon pump (IABP) or Left ventricular assist device (LVAD) before undergoing surgery.
2. Patients undergoing redo operation
3. Chronic renal failure patients requiring regular dialysis or severe renal impairment GFR less than 50 ml/min/1.73 m2
4. Patients with Left ventricular ejection fraction (LVEF) less than 45%
5. Patients with a BMI (Body mass index) more than 35 kg/m2
6. Patients with severe pulmonary hypertension; mean pulmonary artery (mPAP) equal or more than 25 mmHg at rest.
7. Patients with hemodynamic unstable or cardiogenic shock before undergoing surgery
8. Patients with other complications from anesthesia such as anaphylaxis, malignant hyperthermia
9. Patients with severe hepatic failure, Child-Pugh class B and C
10. Patients with severe chronic obstructive pulmonary disease, asthma
11. Patients with a history of schizophrenia, epilepsy, parkinson, sleep disorder, brain injury, have undergone brain surgery.
12. It is a complicated combined procedure such as coronary artery bypass graft with aorta surgery
13. Severe sinus bradycardia before surgery
14. Patients with a history of allergies to drugs used in this research

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain 24 hours after surgery total morphine accumulation in both groups of patients
Secondary Outcome Measures
NameTimeMethod
quality of sleep first night at ICU Richard-Campbell Sleep questionnaire (Thai version) and BIS value,incidence of adverse event related study drug 24 hour after surgery event occur
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