A randomised clinical trial to compare the effectiveness of KETOFOL and KETOFOL-DEXMEDETOMIDINE groups in patients undergoing modified electroconvulsive therapy.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess seizure duration
研究概览
简要总结
A Randomised clinical trial to compare the effectiveness of ketofol and ketofol-dexmedetomidine group in patients undergoing modified electroconvulsive therapy. Patients will be divided randomly into two equal groups, consisting of thirty patients each, the ketofol (K.F. group and ketofol-dexmedetomidine( KFD) group).This study will be carried out in the Department of Anaesthesiology, B.L.D.E.U.’s Shri. B.M. Patil Medical College, Hospital and Research Centre, Vijayapura . The primary outcome is to assess seizure duration and to evaluate an acceptable decrease in heart rate and blood pressure (systolic, diastolic) .The secondary outcome is to assess agitation ,to assess depression , mania, psychosis and to assess early post-M.E.C.T. complications.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with ASA Grade I & II.
排除标准
- •Cardiovascular disease, Cerebrovascular disorder, Intracranial hypertension, Respiratory tract disease, Glaucoma, Presence of a pacemaker, History of seizures, ASA III –V physical status, History of allergy to the study drugs, Pregnancy.
结局指标
主要结局
To assess seizure duration
时间窗: 5 & 10 & 30 minutes after the end of the seizure
To evaluate an acceptable decrease in heart rate & blood pressure (systolic, diastolic)
时间窗: 5 & 10 & 30 minutes after the end of the seizure
次要结局
- To assess agitation
- To assess depression , mania, psychosis(24 hours)
- To assess early post-M.E.C.T. complications.