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临床试验/NCT06473896
NCT06473896招募中不适用

Comparison of the Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Induced Following Treatment With Remifentanil in Patients Undergoing a Laparoscopic Cholecystectomy

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Pain Level

研究概览

简要总结

Analgesia is one of the pillars of anesthesia. One of the common opiates for pain relief, with a short half-life, is Remifentanil. However, following Remifentanil treatment an increased sensitivity to pain [hyperalgesia] appears. The aim of the study is to compare the effects between complementary treatments, like Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain after Remifentanil treatment

详细描述

Analgesia is one of the pillars of anesthesia. For many years, opiates were the basic ingredient in pain relief. The effectiveness of these substances in pain relief caused them to be overused which resulted in a global epidemic of addiction, morbidity and mortality due to the overuse of these drugs. Some of the options for realizing a reduction in the use of opiates include the use of drugs with a more predictable pharmacological profile and a short half-life, such as Remifentanil. This opiate is stronger than Morphine and its half-life remains within a few minutes, without accumulation even after prolonged infusion. Therefore, it seems that the use of remifentanil is ideal, especially for prolonged anesthesia.

One of the severe complications following treatment with Remifentanil is the appearance of increased sensitivity to pain [hyperalgesia] which results from a central sensitivity to pain and is expressed by stimulation of sensory receptors for pain in the nervous system (nociceptive sensitization). In order to alleviate the feeling of pain following the increased sensitivity to pain after treatment with opiates, as well as with Remifentanil, complementary treatments, such as Ketalar and dexmedetomidine, were offered. This study will compare the ability of Ketalar or Dexmedetomidine in alleviating increased sensitivity to pain after treatment with Remifentanil in patients who are candidates for laparoscopic cholecystectomy.

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)

盲法说明

The patients will not be exposed to the treatment arm they will receive

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia

排除标准

  • Patients with sensitivity to the anesthetic
  • Patients with chronic pain who are in regular treatment
  • Urgent surgery
  • Patients with ischemic heart disease
  • Patients with known bradycardia
  • Patients with a pacemaker
  • Prolonged use of opiates
  • Kidney/liver function problems

研究组 & 干预措施

Ketalar

Active Comparator

All patients will undergo general anesthesia using Fentanyl at a dose of 2 mcg/kg, Rocuronium at a dose of 0.6 mg/kg, Isoflurane during surgery and Remifentanil at a dose of 0.2-0.25 mcg/kg/min, 30 Minutes before the end of the operation, Morphine will be given at a dose of 0.1 mg/kg. Each patient will receive paracetamol during surgery.

In addition to the general anesthesia, the patients in the Ketalar group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute.

干预措施: Ketalar (Drug)

Dexmedetomidine

Active Comparator

In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute.

In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Dexmedetomidine at a dose of 0.5 mg/kg for fifteen minutes + Propofol and Fentanyl, and during the operation, continuous Dexmedetomidine at a dose of 0.3 mcg/kg/hour.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Pain Level

时间窗: Up to two hours after the end of the anesthesia process

A record of pain level will be made using the Visual Analogue Scale. The score is determined by marking on 10-cm line between 0 - "no pain" to 10 - "the highest pain".

Pain killer consumption

时间窗: Up to two hours after the end of the anesthesia process

Treatment with morphine for pain relief

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zoya Haitov Ben Zikri

Manager of the anesthesia unit

Assaf-Harofeh Medical Center

研究点 (1)

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