NCT03095469

Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention

Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Injuries

Interventions

Type	Name	Description
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 24h after PCI.
DRUG	0.9%NaCl solution	when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.

Timeline

• Start date: 2017-08-20
• Primary completion: 2017-11-30
• Completion: 2017-12-31
• First posted: 2017-03-29
• Last updated: 2017-06-09

Locations

1 site across 1 country: China