Hyperventilation and ECT Seizure Duration: Effects on Cerebral Oxygen Saturation, and Therapeutic Outcome With Comparisons Between Etomidate and Ketamine in Patients With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- EEG seizure duration (seconds)
研究概览
简要总结
This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of depressive symptoms with and without pre-emptive hyperventilation will also be studied.
详细描述
Electroconvulsive therapy (ECT) is an effective treatment for medication-resistant forms of depression, including major depressive disorder and mania. Therapeutic success of ECT is related to the duration and quality of Electroencephalogram (EEG) and motor seizures. Previous studies have demonstrated that deliberate hyperventilation augments seizure duration in anesthetized subjects. It has also been shown that seizure activity significantly increases cerebral metabolic rate, predisposing the patient to potentially severe cerebral desaturation events. These desaturation events are predicted to be exacerbated by pre-emptive hyperventilation which has a potent cerebral vasoconstrictive effect. Despite the widespread use of ECT, little is known about the effect of hyperventilation on cerebral metabolism in this setting. Ketamine has recently been demonstrated to have anti-depressant properties in patients with major depressive disorder, suggesting that patients treated with ketamine anesthesia and then ECT, may benefit clinically from the additive effects of both treatment modalities, compared to ECT alone.
The investigators hypothesize that hyperventilation will facilitate prolonged seizure duration and faster remission of depressive symptoms. As well there may be significant cerebral desaturation and cardiovascular side effects of ECT therapy following hyperventilation. Lastly, the effect of hyperventilation on the efficacy of ECT therapy may be improved when ketamine anesthesia is used simultaneously. To test this hypothesis this study will compare ketamine anesthesia to etomidate anesthesia. Etomidate is a short acting anesthetic that is commonly used in these procedures.
The study objectives (primary and secondary) are as follows:
- To quantify the effect of hyperventilation and type of anesthetic agent on ECT-induced seizure duration
- To assess the effect of hyperventilation immediately prior to ECT on cerebral metabolism as measured by cerebral oximetry
- To determine the effect of hyperventilation and anesthetic agent on the remission of symptoms in Major Depressive Disorder
- To assess the side effect profile of hyperventilation during ECT on hemodynamics
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients aged 18 to 85 years
- •Diagnosed with Major Depressive Disorder, unipolar or bipolar depression
- •Undergoing ECT for treatment of their symptoms
- •Currently residing in Manitoba
排除标准
- •Relative contraindications to ECT therapy (recent MI or CVA, increased intracranial pressure, intracranial mass lesion, intracranial aneurysm, epilepsy, known cardiac arrhythmia, pheochromocytoma, pregnancy)
- •Contraindications to etomidate (sepsis, primary or secondary adrenal insufficiency, porphyria)
- •DSM-V diagnosis of a lifetime history of psychotic spectrum disorder
- •Drug or alcohol dependence, or abuse within the past 3 months, soy-bean oil allergy
研究组 & 干预措施
ECT with Etomidate
Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose.
干预措施: Etomidate (Drug)
ECT with Etomidate
Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose.
干预措施: Electroconvulsive therapy (ECT) (Procedure)
ECT with Ketamine
Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose.
干预措施: Ketamine (Drug)
ECT with Ketamine
Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose.
干预措施: Electroconvulsive therapy (ECT) (Procedure)
ECT with Etomidate and Hyperventilation
Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
干预措施: Etomidate (Drug)
ECT with Etomidate and Hyperventilation
Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
干预措施: Hyperventilation (Procedure)
ECT with Etomidate and Hyperventilation
Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
干预措施: Electroconvulsive therapy (ECT) (Procedure)
ECT with Ketamine and Hyperventilation
Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
干预措施: Ketamine (Drug)
ECT with Ketamine and Hyperventilation
Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
干预措施: Hyperventilation (Procedure)
ECT with Ketamine and Hyperventilation
Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
干预措施: Electroconvulsive therapy (ECT) (Procedure)
结局指标
主要结局
EEG seizure duration (seconds)
时间窗: Up to 3 minutes post ECT
Duration of seizure spike wave morphology will be assessed by the attending psychiatrist and independently by a second psychiatrist.
ECT-induced seizure duration (seconds)
时间窗: Up to 3 minutes post ECT
Duration of motor seizures will be assessed by timing the onset and offset of appropriate motor twitches in the intrinsic foot muscles and extra-ocular muscles by the attending psychiatrist.
次要结局
- Changes in cerebral metabolism assessed by cerebral saturation (%)(Up to 5 minutes post ECT)
- Remission of depressive symptoms assessed by HAM-D(Approximately one week prior to, and at 2, 4 and 8 weeks post ECT)
- Remission of depressive symptoms assessed by MADRS(Approximately one week prior to, and at 2, 4 and 8 weeks post ECT)
- Effect on blood pressure(Up to 7 minutes post ECT)
- Effect on heart rate(Up to 7 minutes post ECT)
- Duration of stay in post-anesthesia care unit (hours)(Up to 2 hours post arrival in post-anesthesia care unit (PACU).)
- Incidence of nausea in post-anesthesia care unit (%)(Up to 2 hours post arrival in PACU.)
- Incidence of vomiting in post-anesthesia care unit (%)(Up to 2 hours post arrival in PACU.)