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临床试验/CTRI/2025/01/079636
CTRI/2025/01/079636尚未招募4 期

To Compare the effects of Two Different Doses of Propofol on the Hemodynamic Parameters in Patients Undergoing Electro Convulsive Therapy (ECT)

Anaesthesiology Dept, Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Lower Dose of drug shows better hemodynamic stability

研究概览

简要总结

Since its introduction, Electro Convulsive Therapy (ECT) has been used to treat variety of mental diseases which include treatment-resistant depression, bipolar mood disorder, multi-drug resistance, and depression with psychosis. The aim of ECT is to cure particular mental illnesses by applying an electrical charge or amount of current to the frontal lobe of the brain. Anaesthesia has been a component of ECT treatment since the 1950s. It was then called Modified ECT which included muscle relaxants and general anesthetic to lessen stress on the body and mind. Its goals are to lower hazards both during and after ECT procedures and to ensure patients’ comfort. This procedure included patient getting modified anaesthesia by Anaesthesia team.

The goal of Electro Convulsive Therapy is therapeutic effectiveness. Therapy’s Effectiveness depends on each patient getting ECT having high-quality seizure activity. To be classified as having good quality seizure activity, a patient must have motor seizures that last longer than 15 seconds, electroencephalography (EEG) seizures that last longer than 20 sec, and postictal suppression that is greater than 50%. Among the anesthetic drugs frequently used during Electroconvulsive therapy operations is Propofol. Propofol is an anesthetic induction drug with characteristics like a quick onset of action and a quick recovery. The aim of this study is to compare the results of two distinct dosages of Propofol (1.0 mg/kg and 1.5 mg/kg) on hemodynamic parameters, post-seizure apnea time, post-electroconvulsive therapy recovery time, duration of seizures, and quality of seizures. Patients who get lower dose are expected to experience shorter recovery times, better hemodynamic stability, a shorter time to regain consciousness and reduced anxiety and more positive attitude towards ECT without compromising efficacy.

Keywords: Electro Convulsive Therapy, Anesthesia, Propofol

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients (20 to 60 years of age ) Either gender Male and Female Patients included in ASA grade 1 and 2 Patients recommended to receive ECT.

排除标准

  • Patients Refusal Patients with comorbidities such as hypertension, diabetes, bronchial asthma, tuberculosis, acute respiratory disorders, neuromuscular disorders and cardiovascular disorders.
  • Secondary diagnosis of a amnestic disorder, dementia, or delirium, or epilepsy.
  • Pregnancy, Lactation.
  • History of alcohol or Abuse of substances in the year before the start of the study.
  • Allergy to drugs (Propofol and Succinylcholine used in the procedure).

结局指标

主要结局

Lower Dose of drug shows better hemodynamic stability

时间窗: Baseline , 1 minute , 3 minutes , 5 minutes

次要结局

  • Post-seizure apnea time(Post-electroconvulsive therapy recovery time)

研究者

发起方
Anaesthesiology Dept, Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Prachi Pravin Deshmukh

Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital

研究点 (1)

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