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临床试验/NCT03783312
NCT03783312已完成不适用

Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy

Inonu University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative pain scores

研究概览

简要总结

The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration of seizure and postoperative side effects in patients who underwent electroconvulsive therapy .

详细描述

Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment. ECT is used safely in treatment-resistant depression, and in psychiatric disorders such as mania, schizoaffective disorder, schizophrenia, catatonia, and neuroleptic malignant syndrome. Treatment response to ECT in patients with severe depression and mania was reported as 83% and 78%, respectively.

The electrical stimulation applied to the brain in ECT stimulates neuronal cells and a generalized tonic clonic seizure usually occurs for 20 to 60 seconds. ECT is performed 3 times a week for a total of 6-12 sessions.

The exact mechanism of ECT is not known, but (1) release of neurotransmitters such as dopamine, serotonin and norepinephrine (2) hypothalamic release of hormones such as prolactin and endorphins (3) gamma-aminobutyric acid conduction (4) increase in neurotrophic signaling and neurogenesis induction, and (5) factors such as changing the connection between different parts of the brain are thought to play a role.

Although studies have shown the effectiveness of ECT in treatment, low mortality and morbidity rates, and several side effects have been reported. These; oral cavity damage to tongue, teeth, implants or intraosseous denture supports; confusion; dizziness; nausea and vomiting; headache, and myalgia.

The etiology of headache after ECT is not fully understood; however, studies suggest that rapid contraction of the temporalis and masseter muscles due to ECT, vascular changes and serotonergic neurotransmission trigger headache. Headaches have been reported to be mild, moderate or severe and, in some cases, resistant to treatment.

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
Single (Participant)

盲法说明

Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with major depression
  • Patients with American Society of Anesthesiologists (ASA) scores I or II
  • Between 18-65

排除标准

  • Patients with ASA scores III/IV,
  • Under the age of 18,
  • Over the age of 65,
  • Myocardial infarction,
  • Congestive heart failure,
  • Pulmonary disease,
  • Stroke history,
  • Bleeding disorder,
  • Hepatic and renal dysfunction,
  • Pregnant,
  • Migraine history,
  • Allergy of nonsteroidal anti-inflammatory drugs, paracetamol, propofol,
  • Neuromuscular disease,
  • Peptic ulcer disease,
  • Intracranial hypertension,
  • Patients who did not give informed consent

研究组 & 干预措施

placebo

Placebo Comparator

250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.

干预措施: placebo (Drug)

paracetamol

Active Comparator

1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.

干预措施: paracetamol (Drug)

ibuprofen

Active Comparator

800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.

干预措施: ibuprofen (Drug)

结局指标

主要结局

Postoperative pain scores

时间窗: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

Visual Analog Scale (Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various pain. minimum: 0, maximum: 10, 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)

次要结局

未报告次要终点

研究者

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

Erol Karaaslan

Asst. Prof. Dr. Erol Karaaslan

Inonu University

研究点 (1)

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