Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)
Comparison of Three Different Anesthetic Methods in ECT
研究概览
详细说明
Various pharmacological agents have been investigated in the Electroconvulsive therapy (ECT) procedures. Dexmedetomidine, widely used for sedation, attenuates stress-induced sympathoadrenal responses, reduces postoperative agitation, improves intraoperative hemodynamic stability, and decreases anesthetic requirements during a variety of surgical procedures. As an α2-adrenergic receptor agonist, dexmedetomidine has been shown to attenuate the hyperdynamic response associated with ECT. Remifentanil is a potent μ-opioid receptor agonist characterized by its rapid onset and ultra-short duration of action due to rapid metabolism and elimination. An additional advantage of opioid agonists is their ability to suppress sympathetic responses without increasing the seizure threshold. Consequently, short-acting opioid analgesics such as remifentanil have been recommended as adjuncts during ECT because they improve hemodynamic stability, facilitate rapid recovery, and may prolong seizure duration.
Both dexmedetomidine and remifentanil have been widely used for sedation in anesthesia practice for many years, and several studies have evaluated their use during ECT . Furthermore, the prescribing information for both agents indicates that they are approved for sedation in operating rooms and intensive care units.
The primary objective of this study is to compare the effects of dexmedetomidine and remifentanil on the hemodynamic response in patients undergoing ECT. The secondary objectives are to evaluate seizure duration and recovery characteristics. We anticipate that the findings of this study will contribute to the identification of a safer and more effective anesthetic approach for patients undergoing ECT.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Zekine Begeç, Prof.Dr
- 电话号码：3112 904223410660
- 邮箱：zekine.begec@inonu.edu.tr
研究联系人备份
- 姓名：ülkü özgül, prof. dr
- 电话号码：3108 904223410660
- 邮箱：ulku.ozgul@inonu.edu.tr
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
- Patients scheduled for six ECT sessions for a variety of psychiatric conditions
Exclusion Criteria:
- refusal to participate,
- age below 18 or above 60 years
- pregnancy
- asthma
- current use of β-adrenergic blockers
- myocardial infarction within the previous six months
- atrial fibrillation or atrial flutter,
- heart block
- a known personal or family history of hypersensitivity to any of the study drugs
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Control group (Group C)
Whereas patients in the control group (Group C) will receive normal saline infused over 10 minutes (total volume: 30 mL).
Immediately after completion of saline infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg in Group C. If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved.
The total propofol dose administered will be recorded.
Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds.
A suprathreshold electrical stimulus will then be delivered using the ECT device
|
Saline will infused over 10 minutes (total volume: 30 mL)
|
|
有源比较器：Dexmedetomidine group (Group D)
Patients in the dexmedetomidine group (Group D) will receive intravenous dexmedetomidine at a dose of 0.5 μg/kg infused over 10 minutes (total volume: 30 mL).
Immediately after completion of the study drug infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg.
If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved.
The total propofol dose administered will be recorded.
Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds.
A suprathreshold electrical stimulus will then be delivered using the ECT device
|
Dexmedetomidine at a dose of 0.5 μg/kg will infused over 10 minutes (total volume: 30 mL)
|
|
有源比较器：Remifentanil group (Group R)
Patients in the remifentanil group (Group R) will receive intravenous remifentanil at a dose of 1 μg/kg infused over 10 minutes (total volume: 30 mL).Immediately after completion of the study drug infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg.
If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved.
The total propofol dose administered will be recorded.
Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds.
A suprathreshold electrical stimulus will then be delivered using the ECT device
|
Remifentanil at a dose of 1 μg/kg will infused over 10 minutes (total 30 ml)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hemodynamic response
大体时间：Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
|
Arterial blood pressure will be recorded at the following times.
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Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
seizure duration
大体时间：up to ten minutes after electrical stimulation
|
After anesthesia induction patients will administered electrical stimulation and seizure duration will measured.
|
up to ten minutes after electrical stimulation
|
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Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands
大体时间：After seizure in one hour in operation room
|
The time from the end of muscle relaxant administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.
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After seizure in one hour in operation room
|
合作者和调查者
调查人员
- 研究主任：zekine begeç, Prof.Dr
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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