Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial
| Registry | NCT03095469, acronym EODOPWCHD |
|---|---|
| Status | Unknown |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 200 (Estimated) |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University (Other) |
| Conditions | Heart Injuries |
| Interventions | Dexmedetomidine, 0.9%NaCl solution (Drug) |
| Dates | start 2017-08-20 (estimated), primary completion 2017-11-30 (estimated), completion 2017-12-31 (estimated), first posted 2017-03-29, last updated 2017-06-09 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Heart Injuries All trials of Dexmedetomidine All trials of 0.9%NaCl solution
Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has sedative and analgesic effects. Dex currently has been widely used in perioperative management of various surgical.This study intends to verify the effect of heart protection of Dex in perioperative.
Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. Dexmedetomidine and 0.9 % NaCl solution will be transfused when the operation began, ending 24 hours after the surgery. Troponin I level(but are not limited to these data) at pre-operation and 3h, 6h,12h, 24h, 48h after PCI will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 12 months.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| study group | Experimental | Drug: Dexmedetomidine | when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24 h after PCI. |
| control group | Placebo comparator | Drug: 0.9%NaCl solution | 0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * the patients were coincided to CHD combined with depression and anxiety according to diagnostic standard of World Health Organization(WHO)who need receive selective PCI in the First Affiliated Hospital of Xi'an Jiaotong University; * people aged over 18; * patients who will undergo PCI with Hamilton Anxiety scale of 14 points or more. Exclusion Criteria: * severe comorbidity history; * coronary stenosis less than 70%; * severe cardiac dysfunction; * central nervous system disease; * troponin I levels have rised before entering the hospital; * pregnant woman; * history of mental disorders; * alcoholic and long-term use of sedatives and opioids history; * drug allergy history.
| Facility | City | Country | Status |
|---|---|---|---|
| the 1st affiliated hospital of Xi'an Jiaotong University | Xi'an, Shaanxi | China |