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临床试验/NCT02819375
NCT02819375已完成4 期

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Inonu University0 个研究点目标入组 45 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
45
主要终点
seizure activity

研究概览

简要总结

Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and other psychiatric diseases. Currently, most ECT procedures are carried out with muscle paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to establish an accurate balance between adequate anaesthesia depth and optimal seizure duration.

We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol with remifentanil and propofol with ketamine), with respect to seizure duration and seizure quality in patients undergoing electroconvulsive therapy.

详细描述

In this study, 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia. Seven consecutive ECT sessions will evaluated in this study. Exclusion criteria; pregnancy, cerebrovascular disease, epilepsy, unstable cardiovascular disease, chronic obstructive pulmonary disease, and renal or hepatic failure.

Electrocardiogram (ECG), noninvasive arterial blood pressure, and peripheral oxygen saturation (SpO2) measurements will utilized along with standard monitoring techniques in the operating room for patients who did not receive pre-operative medication. A 20-gauge intravenous cannula will placed before induction of patients. Each patient will receive either propofol 1 mg/kg alone (Group P), propofol 0.5 mg/kg and remifentanil 1 µg/kg (Group R), or propofol 0.5 mg/kg and ketamine 0.5 mg/kg (Group K) for their all electroconvulsive therapy session. A pneumatic tourniquet will applied to the arm and then will inflated to isolate blood circulation and allow for an accurate assessment of the motor seizure. Rocuronium (0.3 mg/kg bolus) will administered intravenously and ventilation will assisted using a facemask and 100% oxygen in three groups. Electrostimulus will performed via bifrontotemporal electrodes with a Thymatron System IV ECT Instrument (Somatics Inc.; Lake Bluff, IL, USA) by a psychiatrist who was blind to the study groups. In the initial session, patients will received ECT with 30-50% of the maximum output stimulus, depending on the preference of the psychiatrist. Thereafter, the same psychiatrist will arranged the stimulus amplitudes according to the clinical results of each patient.

The duration of the EEG, motor seizure, and postictal suppression index (PSI) will recorded from the EEG and electromyography traces. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and peripheral oxygen saturation (SpO2) values will taken before anesthesia induction (Tbaseline), after the induction (T0), and following the ECT session at 1 (T1), 3 (T3), and 10 (T10) minutes. Time from the end of rocuronium administration to the time of recovery of spontaneous breathing, time of eye opening, and time of obeying verbal commands will recorded. The presence of complications, such as arrhythmia, laryngospasm, and agitation, will also recorded.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Study include 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who scheduled for ECT sessions under general anesthesia

排除标准

  • Pregnancy
  • Cerebrovascular disease
  • Unstable cardiovascular disease
  • Chronic obstructive pulmonary disease
  • Renal or hepatic failure

研究组 & 干预措施

Group Propofol

Active Comparator

anesthesia will induced 1 mg/kg propofol

干预措施: Propofol (Drug)

Group propofol/remifentanil

Active Comparator

anesthesia will induced 0.5 mg/kg propofol and 1 µg/kg remifentanil

干预措施: Propofol+Remifentanil (Drug)

Group propofol/ketamine

Active Comparator

anesthesia will induced propofol 0.5 mg/kg and ketamine 0.5 mg/kg

干预措施: Propofol+Ketamine (Drug)

结局指标

主要结局

seizure activity

时间窗: intraoperative

Motor (EMG) and electroencephalogram (EEG) seizure durations

次要结局

  • heart rate (HR)((approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes)
  • recovery times(intraoperative)
  • mean arterial pressure (MAP)((approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes)

研究者

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

Ülkü Özgül

Associate professor

Inonu University

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