Pre-medication With Alfentanil vs Placebo During ECT
关键词
抽象
描述
Electroconvulsive therapy is associated with brief hemodynamic alterations that in some patients may be well outside the range of normalcy and potentially dangerous to the patient (Duma A, et al). This cardiovascular response is caused by activation of the autonomic nervous system and consists of an initial parasympathetic response rapidly followed by sympathetically mediated tachycardia and hypertension. The ultra-short acting synthetic opioid alfentanil has a rapid onset and duration of action that mirrors the duration of hemodynamic perturbation associated with ECT while having minimal or no effect on the duration or quality of the seizure. This drug may be effective in blunting the hemodynamic perturbations associated with ECT with a minimal amount of side effects.
日期
| 最后验证: | 01/31/2020 |
| 首次提交: | 11/26/2017 |
| 提交的预估入学人数: | 11/26/2017 |
| 首次发布: | 12/01/2017 |
| 上次提交的更新: | 05/07/2020 |
| 最近更新发布: | 05/11/2020 |
| 实际学习开始日期: | 06/03/2018 |
| 预计主要完成日期: | 02/16/2020 |
| 预计完成日期: | 02/16/2020 |
状况或疾病
干预/治疗
Drug: Alfentanil
Drug: placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Alfentanil | Drug: Alfentanil Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
| Placebo Comparator: placebo | Drug: placebo Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age > /=18 years - Males or females - Anticipating electroconvulsive therapy to treat refractory depressive disorder Exclusion Criteria: - Under the age of 18 - Allergy to alfentanil - Allergy to other standard anesthetic medications utilized in the course of ECT (glycopyrrolate, methohexital, and succinylcholine) - History of malignant hyperthermia - History of severe airway obstruction, bronchospasm or laryngospasm - History of recent myocardial infarction, ventricular arrhythmia - Adverse reaction to ECT requiring premedication with lidocaine or atropine - Non-English speaking - Patients unable to consent for themselves - Current pregnancy |
结果
主要结果指标
1. Systolic blood pressure change [90 minutes]
2. Diastolic blood pressure change [90 minutes]
3. Heart rate [90 minutes]
4. Antihypertensive medication use [90 minutes]
