跳至主要内容
临床试验/CTRI/2025/04/085026
CTRI/2025/04/085026尚未招募不适用

A Study to compare safety and efficacy of ketamine-dexmedetomidine versus ketamine-propofol in post operative mechanically ventilated patients

Pt B D Sharma PGIMS1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年5月10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
1)modified RASS score

研究概览

简要总结

Sedative agent used in critical care unit(ICU) should have to act fast and have to provide ease of titration of dose.it should provide rapid recovery following discontinuation early weaning from mechanical ventilation and early extubation.it has to be safe for all age groups and there should be minimal difference in age related pharmacokinetics.propofol is commonly used in ICU as a sedative agents.its advantage is rapid onset of action and rapid recovery followwing discountinuation but its has its own side effects like bradycardia,arrythmia and propofol infusion syndrome with prolonged continuous infusion.dexmedetomidine,highly selective alpha 2 agonist,has sedative and analgesic effects without causing any respiratory depression,but it may cause biphasic cardiovascular effects in dose dependant fashion.Ketamine ,NMDA receptor antagonist in the CNS,thereby inducing a state of dissociative anaesthesia and at lower dose it has analgesic and antihyperalgesic effects.it prevents respirotory efforts and airway reflexes.it has large therapeutic window but can cause tachyarrythmia and hypertension.contrary to previous literature itnhas been recently demonstraed to have favourable effects on intracranial and intraa abdominalpressures as well,it can be safely used as continuous infusion for short duration.to counteract the adverse effects and to add on the favorable effects,combination of drugs has been used nowadays,in the present literature propofol-fentanyl,midazolam-fentanyl and ketamine-propofol combination has been extensively studied.but  there is paucity of studies for ketamine-dexmedetomidine combination. So the purpose of the study is to find out safety and efficacy of ketamine-dexmedetomidine in detail and to compare with ketamine-propofol combination for sedation in mechanically ventilated patients.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Post operative patients between 18-60 years of age, intubated and shifted to ICU for a period of 12 to 24 hours 2)Afebrile 3)Hemodynamically stable.

排除标准

  • Pateint less than 18 years of age 2)patient with hypotension, Bradycardia, metabolic acidosis.
  • patients with head injury 4)patients requiring neuromascular blocking agents along with sedation 5)pregnancy 6)neurological disease or injury 7)liver or renal insufficiency 8)intraoperative or post operative hemodynamic instability 9)patients on vasopressor or ionotropic support 10)patients with metabolic derangements 11)patients receiving epidural or any other type of analgesia apart from the standardized analgesia used in study.

结局指标

主要结局

1)modified RASS score

时间窗: 1)Modified RASS score will be assessed at starting of infusion(0hr),1Hr,6Hr,12hr and 24hrly | 2)nonverbal pain score will be assessed at starting of infusion(0hr),1hr,6hr,12hr and 24hr | 3)adverse effects will be assessed at any time during continuous intravenous infusion

2)Nonverbal pain score

时间窗: 1)Modified RASS score will be assessed at starting of infusion(0hr),1Hr,6Hr,12hr and 24hrly | 2)nonverbal pain score will be assessed at starting of infusion(0hr),1hr,6hr,12hr and 24hr | 3)adverse effects will be assessed at any time during continuous intravenous infusion

3)adverse effects

时间窗: 1)Modified RASS score will be assessed at starting of infusion(0hr),1Hr,6Hr,12hr and 24hrly | 2)nonverbal pain score will be assessed at starting of infusion(0hr),1hr,6hr,12hr and 24hr | 3)adverse effects will be assessed at any time during continuous intravenous infusion

次要结局

  • 1)Recovery time(2)duration of weaning)

研究者

发起方
Pt B D Sharma PGIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Monica Chhikara

Department of Anaesthesiology and Critical care

研究点 (1)

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