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临床试验/NCT05536362
NCT05536362已完成1 期

Consequences of Co-Administration of Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Measurement of Post-operative Pain

研究概览

简要总结

The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.

详细描述

This study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of IL-8, preserving operation stability, and dropping post-operative pain and morphine intake.

When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake.

For this study, sixty contestants with ASA physical status I and II, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. Using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each).

The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I and II
  • Patients with cancer colon

排除标准

  • participants with a history of heart, renal and liver cell failure.
  • allergic reaction to studied drugs, and history of epilepsy,
  • hydrodynamic instability,
  • chronic pain.
  • mental illness.

研究组 & 干预措施

TCI propofol mixed with clonidine and ketamine

Experimental

Patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine

干预措施: TCI Propofol Injection (Drug)

TCI propofol mixed with a placebo

Experimental

Control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%)

干预措施: TCI Propofol Injection (Drug)

结局指标

主要结局

Measurement of Post-operative Pain

时间窗: 24-hour analgesic after surgery

Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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