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临床试验/NCT04203368
NCT04203368已完成不适用

Efficacy of Adenosine Versus Verapamil for Management of Supraventricular Tachycardia Post- Coronary Artery Bypass Grafting: a Randomized Double Blinded Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
268
试验地点
1
主要终点
efficacy of the study drug

研究概览

简要总结

This prospective study was conducted in 268 patients aged from 65-70 years posted for coronary artery bypass grafting. Patients were randomly allocated to either adenosine or verapamil(control) groups. In the adenosine group, patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil. In verapamil group, patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine. The efficacy of the study drug, ICU stay length, systolic blood pressure, hospital- stay length, duration of extubation, the total dose of the study drug used, the total cost of the study drugs and the incidence of adverse events were recorded.

详细描述

Written informed consent was obtained from every patient. This prospective, double-blind, parallel-group clinical trial was conducted in 268 patients. The following inclusion criteria were used: (1) RCT; (2) adult (age: 65-70 years) patients with ASA physical status II and III, scheduled for elective isolated CABG; (3) use of adenosine versus verapamil for treatment of postoperative supraventricular tachycardia; (4) the efficacy was a mandatory outcome measurement ; (5) Ejection fraction 50-60%; (6) Absence of any associated comorbidities or history of myocardial infarction. Patient with impaired cerebral Perfusion, hemodynamic instability arrhythmias other than PSVT were excluded.

Anesthesia management was standardized to minimize any effect of anesthetic type on hemodynamics. Premedication with midazolam was limited to a maximum of 0.05 mg/kg. Anesthesia was induced with 12 μg/kg fentanyl, 5-7 mg/kg thiopental sodium, and 0.15 mg/kg pancuronium and was maintained with 1-2.0% isoflurane. Heart rate and blood pressure were maintained within 20% of the baseline values. Anticoagulation was achieved with heparin 300 U/kg administered into the right atrium to maintain an activated clotting time above 480 s. Cardiopulmonary bypass (CPB) was conducted with non-occlusive roller pumps, membrane oxygenators, arterial line filtration, and cold blood-enriched hyperkalemic arrest. The CPB circuit was primed with 1.8 l lactated Ringer's solution and 50 ml of 20% mannitol. Management of CPB included systemic hypothermia (to an esophageal temperature of 32°C) during aortic cross-clamping, targeted mean perfusion pressure between 60 and 80 mmHg, and pump flow rates of 2.2 l/min/m2. Myocardial protection was achieved with antegrade cold blood cardioplegia. A 32-μm filter (Avecor Affinity, Minneapolis, MN, USA) was used in the arterial perfusion line. Before separation from CPB, patients were warmed to 36-37°C. After separation from CPB, heparin was neutralized with protamine sulfate and 1 mg/100 U heparin to reach an activated clotting time within 10% of baseline. All patients were transferred to the ICU after surgery.

Patients were randomly allocated to either adenosine or verapamil(control) groups according to a computer-generated randomization code, with allocation ratio 1:1. Opaque sealed envelopes were prepared according to the randomization schedule, and were opened by a clinician not involved in any part of the study. Upon arrival at the ICU, a standardized protocol for postoperative care was implemented for all patients by well-trained nurses supervised 1:1and by the ICU consultants. The study medications were calculated and prepared by ICU nurses who were not a part of the research team. Both end-point assessors of the outcomes and patients were blinded to the study drugs. All staff were blinded to treatment allocation excluding the ICU consultant and resident who were not part of the research team.

To ensure blinding of study drug administration, the medication vials were kept in opaque bags. Trial bags were blinded and marked with a unique number. The allocation of trial drugs was determined by the web-based randomization system by the allocation of the bag number.

In the adenosine group, patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil. In verapamil group, patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 70 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65-70 years old
  • elective CABG

排除标准

  • impaired cerebral Perfusion
  • hemodynamic instability
  • arrhythmias other than PSVT

研究组 & 干预措施

adenosine group

Active Comparator

patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil

干预措施: adenosine (Drug)

verapamil group

Sham Comparator

patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine

干预措施: verapamil (Drug)

结局指标

主要结局

efficacy of the study drug

时间窗: 5 days postoperative

cardioversion to sinus rhythm

次要结局

  • duration of extubation(6-12 hours postoperative)
  • ICU stay(2 days postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hoda Shokri

Assistant professor of Anaesthesiology

Ain Shams University

研究点 (1)

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