跳至主要内容
临床试验/CTRI/2019/05/019456
CTRI/2019/05/019456已完成不适用

Comparative evaluation of effect of propofol and ketofol induction on the incidence of postoperative cognitive dysfunction in adults undergoing general anesthesia- a double blinded randomized controlled study

Deen dayal upadhyay hospital New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
TO OBSERVE THE INCIDENCE OF POST OPERATIVE COGNITIVEDYSFUNCTION AS PER POSITIVE NEUROPSYCHOLOGICAL TESTS IN BOTH THE GROUPS

研究概览

简要总结

Ketamine and Propofol admixture is associated with improved hemodynamics when used as an induction agent. Postoperative cognitive dysfunction is a common adverse event after general anesthesia which represents a decline in a variey of neuropsychological domains including memory, executive functioning and speed of thought processing. Since, Ketamine has dissociativeproperties and Ketofol is being increasingly used for its hemodynamic stability profile, we decide to compare the incidence of  POCD with Ketamine(0.75mg/kg) and Propofol(1.25mg/kg) combination when compared to Propofol(2mg/kg) alone for induction of general anesthesia.

A battery of neuropsychological tests will be used to assess POCD which can be debilitating in day care surgeries.

Neuropsychological tests are Mini mental state examination, California verbal learning test, Digit span test, Stroop card word and colour test.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • ASA 1 AND 2 SURGERY NOT EXPECTED TO CROSS 2 HOURS EDUCATION ATLEAST 10TH STANDARD PASS.

排除标准

  • PATIENT REFUSAL HISTORY OF KNOWN ALLERGY TO DRUGS BEING USED HISTORY OF PSYCHIATRIC ILLNESS DRUG OR ALCOHOL ABUSE AND CHRONIC PAIN HISTORY OF TREATMENT WITH ANTIANXIETY OOPIIOD ANTICONVULSANTS AND ANTIPYSCHOTIC DRUGS PREGNANT AND LACTATING WOMEN PATIENT WITH HISTORY OF ALZHEIMERS DISEASE AND MMSE SCORE LESS THEN 23.

结局指标

主要结局

TO OBSERVE THE INCIDENCE OF POST OPERATIVE COGNITIVEDYSFUNCTION AS PER POSITIVE NEUROPSYCHOLOGICAL TESTS IN BOTH THE GROUPS

时间窗: POST OPERATIVE 5 MINS, 30 MINS , 1 HOUR, 2 HOUR AND 4 HOUR

次要结局

  • To correlate Richmond agitation sedation scale wth incidence of positive neuropsychological tests for POCD.(To assess the relation of age and education on POCD in ketofol and propofol group.)

研究者

发起方
Deen dayal upadhyay hospital New Delhi
申办方类型
Other []

研究点 (1)

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