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临床试验/NCT04976374
NCT04976374Unknown不适用

A Multimodal Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment After Modified Radical Mastectomy Surgery: A Randomized Placebo-Controlled Study

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月25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
发起方
入组人数
30
试验地点
1
主要终点
Post operative morphine consumption

研究概览

简要总结

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study

详细描述

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study.

Dexmedetomidine is a highly selective X2 adrenergic receptor aganist; it has anxiolytic, sedative, analgesic and sympathdytic properties without significant respiratory depressant effects. Research evidence has shown that this drug protects the body (including heart, nerves, etc.) against ischemia and hypoxic injury. Therefore, dexmedetomidine can be one of the best options for reducing pain after surgery.

Gabapentin, a structural analog of gamma aminobutyric acid, is used as an anticonvulsant drug since 1993. In addition it has been effective in neuropathic pain, diabetic neuropathy and reflex sympathetic dystrophy. It acts through binding to the X-2-5 subvnits of voltagegated calcium ion channels and preventing the central sentization and hyperalgesia. Gabapentin has demonstrated to inhibit the development and establishment of hyperalgesia and secondry allodynia in human volunteers.

Gabapentin may also decrease postoperative obioid requirement through preventing the tolerance development. Furthermore, it has minimal or no effect on gastric mucosa, renal function, and platelets count or activity in the perioperative period to be prefer over nonsteroidal anti-inflammatory drugs.

The Combination of both drugs will be tested for potentiation of post-operative analgesia and decrease of opioid consumptions

研究设计

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

入排标准

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

入选标准

  • adult female patients below 65 years of age scheduled for modified radical mastectomy surgery, American society of Anesthesiologists(ASA) physical status I-II

排除标准

  • known allergy to study drugs; patients already taking oral gabapentin, knal or hepatic defunction, current treatment with narcotics, antihypertensives, benzodiazepines, X2 agonists, antiepileptics and antipsychotics

研究组 & 干预措施

Group A

Active Comparator

Patients of group A will start dexmedetomidine (precedex 100 ug lmL, Hospira) infusion 0.4 ug {Kg}h after bolus of 0.5 ug 1 kg intravenously over 10 min

干预措施: Dexmedetomidine and Gabapentin (Drug)

Group B

Placebo Comparator

Group B will recive a bolus of saline then saline infusion identical to group A

干预措施: Saline (Other)

结局指标

主要结局

Post operative morphine consumption

时间窗: 24 hours

Evaluation of the effects of combining and gabapentin and dexmedetomidine infusion on post operative morphine consumption within the first 24 h in patients undergoing modified radical mastectomy surgery

次要结局

  • Post operative VAS score(24 hours)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Bakir

Assistant Professor of Anesthesia, Intensive care and Pain Relief

National Cancer Institute, Egypt

研究点 (1)

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