Comparison of psychomotor recovery of intravenous dexmedetomidine bolus with intravenous subanaesthetic ketamine in patients undergoing general anaesthesia: A prospective randomized double blind study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- to compare the psychomotor recovery profile of patients
研究概览
简要总结
Dexmedetomidine an α 2 agonist has replaced propofol as primary maintenance anaesthetic.
Ketamine, an N-methyl aspartate antagonist(NMDA antagonist), at subanaesthetic doses, poses centrally mediated analgesic property with minimum effect on consciousness and cognition.
it is aimed to replace the bolus dose of dexmedetomidine with subanaesthetic dose of ketamine for better hemodynamic stability.
Psychomotor tests address the intermediate recovery of the patient and also it denotes the restoration of the patient to street fitness.
Digit symbol substitution test, a form of pen and pencil test used for assessing cognition, memory attention ,and it also correlates with real world functional outcomes like the ability to accomplish everyday tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •1.age between 18-65 years 2.ASAPS I, II III
- •Patients scheduled for surgeries under general anaesthesia.
- •Minimum duration of surgery lasting more than 180 minutes.
排除标准
- •Patients unwilling to participate in the study.
- •Patients who are unable to give informed consent.
- •Patients with known history of psychiatric illness, chronic drug or alcohol abuse.
- •Patients with known hypersensitivity to drugs used.
- •Pregnant and lactating women.
- •BMI>30kg/m 2 .
- •Patients on concurrent sedative medications.
- •Patients who are unable to attempt or perform the DSST test.
结局指标
主要结局
to compare the psychomotor recovery profile of patients
时间窗: to compare the psychomotor recovery profile of patients | receiving either IV dexmedetomidine bolus (Group D) or subanaesthetic ketamine bolus | (Group K) by Digit Symbol Substitution Test (DSST) postoperatively at 15,30,60,90,120 minutes post extubation
receiving either IV dexmedetomidine bolus (Group D) or subanaesthetic ketamine bolus
时间窗: to compare the psychomotor recovery profile of patients | receiving either IV dexmedetomidine bolus (Group D) or subanaesthetic ketamine bolus | (Group K) by Digit Symbol Substitution Test (DSST) postoperatively at 15,30,60,90,120 minutes post extubation
(Group K) by Digit Symbol Substitution Test (DSST) postoperatively at 15,30,60,90,120 minutes post extubation
时间窗: to compare the psychomotor recovery profile of patients | receiving either IV dexmedetomidine bolus (Group D) or subanaesthetic ketamine bolus | (Group K) by Digit Symbol Substitution Test (DSST) postoperatively at 15,30,60,90,120 minutes post extubation
次要结局
- to Compare Postoperative sedation(15,30,60,90,120 minutes postoperatively)
- time to first request of analgesia(postoperatively)
- hemodynamic changes(post induction immediately)
- additional boluses of fentanyl given(intraoperatively)
- propofol boluses given(intraoperatively)
研究者
Dr Kancharla Manikumar
Sri venkateswara institute of medical sciences