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临床试验/CTRI/2024/05/067093
CTRI/2024/05/067093尚未招募不适用

Comparison of corrected carotid flows after induction with propofol using Target controlled infusion versus Manual boluses in the elderly population undergoing General Anesthesia- A Randomized Controlled Trial

AIIMS BHUBANESWAR1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
To compare the change in corrected carotid flows(FTc) just after induction from the baeline with the propofol using Target controlled infusion versus manual boluses in the elderly population undergoing General Anesthesia

研究概览

简要总结

Post induction hypotension is most encountered during anesthesia and surgery. Especially, Elderly population are more prone to hemodynamic instability. Hypotension is related to many adverse outcomes, in severe hypotension, perfusion to organs will be compromised which may increase post operative morbidity and mortality. Propofol is one such common drug that is widely used as IV induction agent and can cause hypotension. Hypotension also relate to carotid blood flows which if decrease, hampers cerebral blood flow. Induction with Target controlled infusion(TCI) pump is known to provide better hemodynamic stability than manual boluses, which is a regular practice. To the best of our knowledge, comparison of corrected carotid flows using ultrasonography after induction with propofol using Target controlled infusion(TCI) versus manual boluses, has not been studied yet. So, in this study we will compare corrected carotid flows after induction from the baseline in TCI and manual boluses group.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Elderly population of 60 years or greater and ASA 1/2 undergoing General Anesthesia with endotracheal intubation.

排除标准

  • Patients who will refuse to participate in the study 2)BMI 30 or greater 3)Patients having egg allergy 4)DM with autonomic dysfunction 5)Patients with severe cognitive dysfunction 6)Patients with severe liver dysfunction 7)Patients in shock or coma patients or emergency cases 8)Preexisting tracheal intubation, tracheostomy or more than 1 attempt to intubate the patient 9)Patients with uncontrolled hypertension.

结局指标

主要结局

To compare the change in corrected carotid flows(FTc) just after induction from the baeline with the propofol using Target controlled infusion versus manual boluses in the elderly population undergoing General Anesthesia

时间窗: Preoperative period and intra operative period

次要结局

  • To determine the correlation of baseline corrected carotid flows (FTc) with post induction hypotension (PIH) in either group.(Intraoperative period)
  • To compare the incidence of PIH and time for onset of PIH among the groups.(Intraoperative period)
  • To compare FTc and other doppler parameters during hypotension in PIH subgroup(Intraoperative period)
  • To compare the time for induction and total dose of propofol used for induction among the groups.(Intraoperative period)
  • To compare the incidence of post operative delirium among the groups(Preoperative, intraoperative and within 5 days in postoperative period)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kappa Venkata Anusha Sree

AIIMS BHUBANESWAR

研究点 (1)

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