A comparative study of effectiveness of propofol and ketamine as induction agent for electro convulsive therapy in patient with severe depression.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- A)
研究概览
简要总结
This clinical trail is a comparative study of propofol and ketamine as induction agents for electro convulsive therapy in patients with severe depression.
This is a double blinded study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both sexes between age 18-65 years.
- •Patients with severe depressive disorder requiring electro convulsive therapy.
- •Patients with American Society of Anaesthesiology (ASA) physical status l & ll .
排除标准
- •Pregnant females and lactating mothers.
- •Patients on chronic opiate use such as tramadol.
- •Known allergies to study drugs.
- •Patients with hypertension, IHD and other heart diseases.
结局指标
主要结局
A)
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
1)Mean blood pressure
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
2)Heart rate
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
3)Oxygen Saturation
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
B)
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
1)Spontaneous eye opening
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
2)Obeying verbal commands
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
C)
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
MADRS(Montgomery Asberg Depression Rating Scale)
时间窗: A) | 2min before premedication | 2min after induction | 5min, 10min, 15min, 20min after giving shock and onset of seizures | B) | 0min, 5min,10min, 15min post ect | C) | 1st & 2nd week post ect
次要结局
- Seizure duration(10 min after induction)
- Incidence & severity of post ect agitation(15 min post ect)
- Incidence & severity of post ect myalgia(6hrs & 12hrs post ect)
研究者
Kapuri Manasa
Mahatma Gandhi Missions Medical College and Hospital