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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210322007
Enrollment
48
Registered
2021-03-22
Start date
2021-10-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients underwent cardiac surgery after ultra-fast track endotracheal extubation. Patients underwent cardiac surgery after ultra-fast track endotracheal extubation.

Interventions

Dexmedetomidine group n 24 Patients receive continuous infusion of low dose dexmedetomidine ,Placebo group N 24 Patients receive normal saline with the same volume as Dexmedetomidine group
Experimental Drug,Placebo Comparator Drug
Patients received dexmedetomidine ,Patients receive normal saline

Sponsors

Siriraj Research Fund, Faculty of medicine Siriraj Hospital Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pain 24 hours after surgery total morphine accumulation in both groups of patients

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactSaranya Lertkovit

Department of Anesthesiology Faculty of Medicine Siriraj Hospital

saranya.oaw@gmail.com66819640322

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026