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临床试验/CTRI/2018/08/015218
CTRI/2018/08/015218尚未招募不适用

A Comparative Study of Etomidate and Propofol as Induction Agents in Modified Electroconvulsive Therapy

Samiksha kumari1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Measurement of motor seizure duration in isolated limb in seconds for both the drugs

研究概览

简要总结

A  COMPARATIVE  STUDY OF  ETOMIDATE  AND PROPOFOL  AS  INDUCTION AGENTS  IN  MODIFIED ELECTROCONVULSIVE THERAPY

INTRODUCTION: Modified ECT is used in refractory psychiatric illnesseswith anaesthesia to avoid trauma to the patient physically and psychologically.Propofol and etomidate are short acting iv anaesthetic agents used in ECT.

AIMS AND OBJECTIVES: 1) To studypropofol in terms of induction time, motor seizure duration, hemodynamicparameters, recovery time and adverse effects. 2)To study etomidate in terms of induction time, motor seizure duration, hemodynamicparameters, recovery time and adverse effects. 3)Comparison of propofol and etomidate in terms of induction time, motorseizure duration, hemodynamic parameters, recovery time, adverse effects inmodified electroconvulsive therapy.

MATERIAL AND METHODS: The study will be conducted inDepartment of Anaesthesiology, GGS Medical College, Faridkot. INCLUSION CRITERIA 1)Adultpatients of equal number of males and females, aged between 18 and 55 years. 2)Patientsbelonging to American Society of Anesthesiologist Grade I and II. 3)Patientsscheduled for electroconvulsive therapy. EXCLUSIONCRITERIA 1)Patientor relatives refusal for electroconvulsive therapy or both. 2)Patients with known allergy to thestudy drug. 3)Patients with full stomach,neuromuscular disorders, displaced bone fractures, severe osteoporosis.3)Patients with history of recent myocardial infarction (<3 months), recentcerebrovascular accident or raised ICP. 4)Patients with epilepsy 5)Patientswith hypopituitarism and major illnesses like bronchial asthma andtuberculosis. 6)Pregnant patients. 7)Agitated patients requiring additionalsedation. 7)ASA grade III and IV patients.

Writteninformed consent will be obtained from each patient. 70 patients scheduled forelectroconvulsive therapy at Department of Anaesthesia, GGSMCH, Faridkot willbe randomly assigned to one of two general anaesthetic groups.

GroupA patients will recieve propofol 1.0 mg/kg and Group B patients will receive etomidate0.2 mg/kg as induction agents respectively and motor seizure duration of thetwo drugs will be measured.

Intra–operatively, motor seizure duration, induction time, hemodynamic and recoveryparameters and any adverse effects will be noted. Following ECT, patients willbe assessed by patient satisfaction score and emergence agitation score.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of equal number of males and females, aged between 18 to 55 years.
  • Patients belonging to American Society of Anesthesiologist Grade I and II.
  • Patients scheduled for electroconvulsive therapy.

排除标准

  • Patient or relatives refusal for electroconvulsive therapy or both.
  • Patients with known allergy to the study drug.
  • Patients with full stomach, neuromuscular disorders, displaced bone fractures, severe osteoporosis.
  • Patients with history of recent myocardial infarction (<3 months), recent cerebrovascular accident or raised ICP.
  • Patients with epilepsy 6)Patients with hypopituitarism and major illnesses like bronchial asthma and tuberculosis.
  • Pregnant patients.
  • Agitated patients requiring additional sedation.
  • ASA grade III and IV patients.

结局指标

主要结局

Measurement of motor seizure duration in isolated limb in seconds for both the drugs

时间窗: Measurement of motor seizure duration in isolated limb in seconds just after giving electric shock for both the drugs

次要结局

  • Recovery parameters(Any side effects)

研究者

发起方
Samiksha kumari
申办方类型
Other [self]

研究点 (1)

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