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临床试验/CTRI/2020/07/026647
CTRI/2020/07/026647招募中不适用

Comparative study between lignocaine and two different doses of dexmedetomidine on the attenuation of hemodynamic stress response in patients posted for elective oncosurgeries

Kidwai memorial insitute of Oncology1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2020年7月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
210
试验地点
1
主要终点
No increase in Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure with the intervention drug as compared to the baseline

研究概览

简要总结

Hemodynamic stress response or the Pressor response to laryngoscopy  and intubation is very detrimental in cancer patients as they are weak due to the malignancy itself and due to concurrent treatment like Radiotherapy and chemotherapeutic drugs many of which have major side effects

There is always a need for an agent to overcome this response without any adverse effects

Dexmedetomidine is an alpha 2 adrenoceptor agonist which has the capability to totally blunt the hemodynamic stress response during laryngoscopy and intubation. But, Higher loading doses have known to cause side effects like Bradycardia and Hypotension which maybe counter productive in cancer patients as it leads to other complications that may alter intraoperative management and thereby postoperative recovery.. Hence if lower doses of dexmedetomidine can blunt this hemodynamic response without the side effects of bradycardia and hypotension, it would be of great help in the intraoperative management and early post op recovery of the cancer patient

Lignocaine is a local anesthetic which has been known to reduce the hemodynamic stress response to laryngoscopy and intubation but not blunt it completely. We want to give an active drug instead of a placebo as it may be of some benefit to the already ailing cancer patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant 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

  • Patients consenting for study American society of anesthesiologists (ASA) status 1 and 2 Patients undergoing elective oncosurgeries.

排除标准

  • Patient refusal History of allergy to study drug Patients on Calcium channel blockers, beta blockers, ACE inhibitors Anticipated difficult airway More than two attempts at intubation History of Cerebrovascular accident, Ischemic Heart disease, Chronic Obstructive lung disease, Chronic Hypertension Impaired Renal function tests Impaired Liver function tests.

结局指标

主要结局

No increase in Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure with the intervention drug as compared to the baseline

时间窗: Baseline values | Before induction | before intubation | 1 min after intubation | 3 mins after intubation | 5 mins after intubation | 10 mins after intubation

次要结局

  • Development of Hypotension and Bradycardia with Study drug(Baseline before study drug administration)

研究者

发起方
Kidwai memorial insitute of Oncology
申办方类型
Research institution and hospital

研究点 (1)

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