Comparison of Three Different Anesthetic Methods in ECT
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Hemodynamic response
研究概览
简要总结
Electroconvulsive therapy (ECT) is a treatment modality that induces therapeutic seizures through electrical stimulation for the management of certain psychiatric disorders. Nearly all ECT procedures are performed under general anesthesia. However, ECT is commonly associated with acute hyperdynamic responses immediately following electrical stimulation, including transient hypertension and tachycardia. These acute hemodynamic changes may pose significant risks, particularly in patients with ischemic heart disease, hypertension, or cerebrovascular disease. Therefore, the hemodynamic response, seizure quality, and recovery profile are critical factors influencing the choice of anesthetic and adjuvant agents. The primary goal of anesthesia for ECT is to maintain hemodynamic stability without compromising seizure duration or quality while ensuring rapid and safe recovery
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study medications will be prepared by an anesthesiologist who is not involved in patient management or data collection. The study drugs will be prepared in the same volume and administered at the same rate. Neither the anesthesiologist nor the patient will know which drug is being administered
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
- •Patients scheduled for six ECT sessions for a variety of psychiatric conditions
排除标准
- •refusal to participate,
- •age below 18 or above 60 years
- •pregnancy
- •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
研究组 & 干预措施
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
干预措施: Saline (0.9% NaCl) (Drug)
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
干预措施: Dexmedetomidine (Drug)
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
干预措施: Remifentanil (Drug)
结局指标
主要结局
Hemodynamic response
时间窗: 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.
次要结局
- seizure duration(up to ten minutes after electrical stimulation)
- Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands(After seizure in one hour in operation room)