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

Xi'an Jiaotong University

Status and phase: Unknown; Early Phase 1

Conditions: Heart Injuries

Treatments: Drug: Dexmedetomidine; Drug: 0.9%NaCl solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03095469

XJTU1AF-CRF-2016T-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

control group

Placebo Comparator group

Description:

0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI.

Treatment:

Drug: 0.9%NaCl solution