A Pilot Study to Investigate the Efficacy and Safety of Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures for Treatment of a Tachyarrhythmia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of haemodynamic events requiring intervention
研究概览
简要总结
To evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at TGH for sedation in patients undergoing ablation procedures for atrial fibrillation (AF) and atrial flutter.
The investigators hypothesise that dexmedetomidine will be at least equivalent to, or more so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for sedation during ablation procedures.
详细描述
The role of ablation for chronic persistent AF has been debated amongst cardiologists for some time, and there is increasing evidence that ablation may be superior to medical management. As populations age, the rate of AF is likely to increase and therefore the numbers of ablations performed for this arrhythmia will also be expected to increase.
Ablation procedures can vary in length from one to more than 6 hours in duration and require the patient to keep still so as not to influence the mapping procedure.
Options for anaesthesia care include a general anaesthetic or sedation. Several studies have evaluated the safety of sedation for ablation, using combinations of fentanyl, midazolam and propofol. These demonstrate that the ablation procedures are well tolerated under deep sedation.
Dexmedetomidine is an attractive potential agent for this role due to its favourable respiratory pharmacodynamics and good sedation profile. Dexmedetomidine is a short acting relatively specific alpha-2 receptor agonist (alpha 2: alpha 1 = 1300:1). It has been shown to have very little effect on respiratory parameters, even at high doses.In addition, it may offer some analgesic properties and therefore minimise the need for narcotic based agents. the investigators will compare dexmedetomidine infusion and fentanyl bolus with remifentanil infusion midazolam bolus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients will be randomly allocated (computer generated) to receive either a dexmedetomidine infusion or a remifentanil infusion.
The patient, interventional cardiologist and data analyser will be blinded to the drugs given. The anaesthesia care provider will not be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist
- •Valid consent
排除标准
- •Baseline HR <40
- •Baseline SBP < 80mmHg
- •Baseline SBP > 180mmHg
- •Second or third degree heart block unless pacemaker in situ
- •Uncontrolled heart failure/severe LV dysfunction (Ejection fraction < 40%)
- •Severe hepatic dysfunction (Transaminases greater than 2 times the upper limit of normal)
- •Renal dysfunction: estimated GFR < 30ml/min, or requiring dialysis
- •Allergy to any of the study drugs (dexmedetomidine, remifentanil, fentanyl, midazolam)
- •Cognitive impairment precluding ability to tolerate sedation and comply with assessment methods
- •Requirement for general anaesthetic for the procedure
- •Pregnancy or breast feeding mothers
- •Chronic use or addiction to opioids
- •< 18 years of age
研究组 & 干预措施
Dexmedetomidine Group
The study drug dexmedetomidine (PrecedexTM) is supplied as dexmedetomidine HCL 200mcg/vial (100mcg/ml). This will be added to 98 ml 0.9% NaCl to achieve a concentration of 2mcg/ml and infused at 0.2-1mcg/kg/hour from the start of the case. The infusion rate will be commenced at 1mcg/kg/hour in those less than or equal to 65 years of age, and at 0.7mcg/kg/hr in those greater than 65 years of age, and then titrated based on the intraoperative sedation scores (to achieve a Sedation and Agitation scale (SAS) score of less than or equal to 4) and cardiovascular parameters (within 30% of baseline).
干预措施: Dexmedetomidine group (Drug)
Remifentanil Group
Remifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline)
干预措施: Remifentanil Group (Drug)
结局指标
主要结局
Number of haemodynamic events requiring intervention
时间窗: up to 24 hours
a.Hypotension i. A decrease of 30% or more from baseline ii. Or absolute cut off values of 1. SBP \< 80mmHg 2. DBP \<40mmHg iii. Number of events and total dose of phenylephrine or ephedrine administered. b. Hypertension i. An increase in Systolic blood pressure 30% or more from baseline ii. Or an absolute cut off value of \> 180mmHg iii. Total number of events c. Bradycardia i. A decrease of 30% or more from baseline ii. Or absolute cut off values of \< 40bpm iii. Total number of events and total dose of glycopyrolate or atropine administered.
Number of respiratory events requiring intervention
时间窗: up to 24 hours
Respiratory events requiring intervention 1. Respiratory rate \< 6 breaths/min 2. Airway obstruction requiring manual support 3. Airway obstruction requiring guedel insertion 4. Apnoea (cessation of respiration \>10seconds) 5. Hypoxia (saturations \<90% for \>20 seconds)
次要结局
- Post operative nausea and vomiting (PONV)(up to 24 hours)
- Intraoperative pain scores(up to 24 hours)
- Intraoperative sedation scores(up to 24 hours)
- Recovery time(up to 24 hours)
- Length of stay in the recovery unit(up to 24 hours)
- Analgesia requirements(up to 24 hours)
- Patient satisfaction(up to 48 hours)
- Itch(up to 24 hours)
研究者
Jo Carroll
Manager Anesthesia Research
University Health Network, Toronto