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临床试验/NCT03037073
NCT03037073已完成2 期

Impact of Duloxetine on Succinylcholine-induced Postoperative Myalgia During Direct Microlaryngoscopic Surgeries: Randomized Controlled Double-blind Study

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Four-point scale for myalgia

研究概览

简要总结

For >60 years, succinylcholine is still being administered as a selective relaxant for rapid sequence intubation by anesthesiologists in many countries. It has been shown to possess unique features such as low cost, fast-acting, short half-life, safe metabolites, and causing excellent muscle relaxation for intubation. It has many side effects as well. Postoperative myalgia (POM), with an incidence rate of ~41%-92%, is one of the most common side effects of this drug and can take several days to cause significant discomfort in patients. However, its effect is felt more in the throat, neck, shoulder, and abdominal muscles and is common among patients with outpatient surgery. Due to its unknown real context of pathogenesis and in an effort to reduce the incidence and severity of succinylcholine-induced myalgia, various medications including nondepolarizing muscle relaxants, benzodiazepines, magnesium sulfate, opioids, gabapentin, and nonsteroidal anti-inflammatory drugs have been tested, with varying degrees of success.

Duloxetine is an US Food and Drug Administration-approved analgesic used for various pain syndromes, including diabetic peripheral neuropathy and fibromyalgia. The underlying mechanism for duloxetine against these pain syndromes remains unclear, but it may involve three major central nervous system (CNS) targets: (1) serotonin transporter (Ki, 4.6 nM), (2) norepinephrine transporter (Ki, 16 nM), and (3) dopamine transporter (Ki, 370 nM). In the past, the antidepressant action was often thought to be the primary mechanism for its analgesic efficacy. This theory was addressed later by "Path Analysis," and the result showed that duloxetine affects pain directly rather than indirectly through mood improvement. In addition to these multiple CNS targets, duloxetine, like the antidepressant amitriptyline and the local anesthetic bupivacaine, blocks voltage-gated Na+ channels. Because neuronal Na+ channels are present in both CNS and peripheral nervous systems, such a finding expands the possible analgesic action and locus of duloxetine.

详细描述

Eligibility and type of the study: This prospective randomized placebo-controlled double-blind study will be conducted after approval from the Institutional Ethics Committee and obtaining written informed consent from patients undergoing elective direct microlaryngoscopic surgeries under general anesthesia.

Sample size: Sample size calculation is based on the pilot study, where the incidence of POM in outpatient cases is found to be more than 70% and intervention that can cause 25% reduction in incidence of POM will be interesting. With a power of 90% and type I error of 5%, 32 patients will be required in each group (α=0.05 and β=90%), but to avoid possible loss of samples (dropouts) during the study, the number of patients in each group will be increased to 35 to be a total of 70 patients.

Patients: Seventy patients will be enrolled in this study. They will be equally divided into two groups. Group D (duloxetine group): 35 patients will receive duloxetine (Cymbalta; Eli Lilly & Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia. Group C (control group) 35 patients will receive similar-looking placebo capsules (starch capsules) orally with sips of water, 2 h before induction of anesthesia.

Anesthetic Technique and Data Collection: The patients will not be pre-medicated. The study drugs will be given to patients by another anesthesiologist blinded to the envelops coding. No IM injections will be administered during the perioperative period.

Two days before surgery, patients will visit the outpatient clinic for assessment and explanation about the study protocol. Laboratory investigations will be performed and patients will be informed that they can stop participation in the study at any time without any loss of service.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 20-60 years
  • either sex
  • ASA physical status I or II

排除标准

  • known allergy to duloxetine, abnormal renal and liver function tests, history of chronic pain
  • regular medication with SNRI or analgesics (excluding acetaminophen and nonsteroidal anti-inflammatory drugs)
  • patients with a history of seizure disorders
  • hyperkalemia
  • systemic illness like hypertension
  • increased intracranial and intraocular pressure
  • pregnant or breast-feeding females.

研究组 & 干预措施

Group D

Active Comparator

35 patients will receive duloxetine (Cymbalta; Eli Lilly & Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia.

干预措施: Duloxetine (Drug)

Group C

Active Comparator

35 patients will receive similar-looking placebo capsules (starch capsules) orally with sips of water, 2 h before induction of anesthesia.

干预措施: Placebo oral capsule (Drug)

结局指标

主要结局

Four-point scale for myalgia

时间窗: 24 hours

Myalgia is defined as "a pain with no surgical interference"

次要结局

  • Four-point scale for fasciculations(5 minutes)
  • Ramsay sedation score(24 hours)
  • Postoperative Complications(24 hours)

研究者

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

Mohamed F. Mostafa

Lecturer of Anesthesia and Intensive Care

Assiut University

研究点 (1)

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