跳至主要内容
临床试验/NCT01632657
NCT01632657已完成不适用

Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Quality of Recovery

研究概览

简要总结

Postoperative migrainous headache following craniotomy is distressing and may cause significant morbidity and often delay discharge from the hospital. The mechanism of this post craniotomy migraine is multifactorial. Possible causes include the intraoperative loss of cerebrospinal fluid leading to stretching of the dura, traction on intracranial vessels and meningeal irritation. There are two groups of patients who undergo elective minimally invasive craniotomies and yet have considerable postoperative migraine headache postoperatively. These are patients who have a craniotomy for clipping of an unruptured cerebral aneurysm and patients who require a microvascular decompressive craniotomy for cranial nerve pain such as trigeminal neuralgia. Their postoperative migrainous headache often impairs the quality of their recovery and may even delay discharge from hospital. Opioid analgesics are not always effective and may also worsen the postoperative nausea and vomiting and in turn postoperative quality of their recovery. Sumatriptan is a drug that has been used for decades for the treatment of migraine headaches. It acts on 5hydroxytryptophan receptors, which are located in the dura mater (lining of the brain) and are also located around the cranial trigeminal nerve ganglion. Thus sumatriptan may be an effective to improve postoperative migraine , nausea and vomiting and overall quality of recovery. We plan to do a randomized double blind placebo controlled trial on the effect of Sumatriptan for postoperative migraine on the postoperative quality of recovery after elective minimally invasive craniotomies. A total of 92 patients scheduled to undergo minimally invasive craniotomy for either clipping of an unruptured aneurysm or microvascular decompression for cranial nerve neuralgias will be included in this study. Patients within the 2 surgical groups with postoperative migraine will then be block randomized to receive either 6mg of sumatriptan subcutaneously or placebo following assessment in the post operative care unit (PACU). The primary outcome measure will be quality of recovery at 24 hours using Quality of recovery 40 Questionnaire (QoR-40). Our secondary outcome will be postoperative pain, analgesic consumption, side effects and hospital discharge times.

详细描述

Recently there have been changes in the surgical management of many patients who have an unruptured cerebral aneurysm and or cranial nerve neuralgia pain. The surgical technique now consists of a minimally invasive craniotomy that is less invasive with a smaller incision, shorter duration of procedure and in some patients the possibility of going home the same day, Postoperative surgical pain from the incision itself is usually minimal and they are usually managed very well with combination of both opioid and non-opioid analgesics such as fentanyl, morphine, hydromorphone, codeine, oxycocet, oxycontin and acetaminophen. In addition, up to 65% patients undergoing craniotomy may suffer from post craniotomy headache and the incidence may be higher after posterior fossa craniotomy. (1) Patients often complain of severe migraine headache associated with photophobia, nausea and vomiting and general feeling of unwell. These discomforts often delay discharge from the hospital and affect the quality of recovery. (2,3) Post craniotomy surgical pain usually decreases significantly after 24 hours whereas post craniotomy migraine headache, which may be a separate entity, continues for a longer period of time. (4) This migraine headache is in different location from the surgical incision and the conventional treatments of post surgical pain are ineffective against migraine headache.(5) Hence these patients usually suffer a lot after minimally invasive craniotomy. The mechanisms of postoperative migraine are also poorly understood and may be multifactorial including raised intracranial pressure, traction on intracranial blood vessels or meningeal irritation. (6) These factors activate the trigeminal afferent C fibres that reside on pial and dural blood vessels. This causes transmission of pain and release of neurogenic peptides activating an inflammatory cascade causing vasodilation and perivascular inflammation. The loss of cerebrospinal fluid is another factor.(7) With a minimally invasive craniotomy, loss of cerebrospinal fluid is unavoidable as it is needed for better surgical access. Serotonin (5-hydroxytryptophan) is a neurotransmitter that is thought to contribute to the feeling of wellbeing. There are receptors for 5hydroxytryptophan (5-HT) located in the central nervous system especially in the trigeminal nerve both near the dura as well as in brainstem (near the trigeminal nuclei) and also located on vascular endothelium and smooth muscle in meningeal blood vessels as well as in neuronal tissue.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having elective craniotomy for clipping of unruptured intracranial aneurysm
  • Patients having craniotomy and microvascular decompression for cranial nerve neuralgia

排除标准

  • Patients with a known history of hypersensitivity to Sumatriptan or sulphonamides
  • Patients with a known history of Migraine
  • Patients who is on regular treatment with Sumatriptan
  • Patients with history of Ischemic heart disease - Angina, Myocardial infarction.
  • Patients who had rupture of their intracranial aneurysm.
  • Patients with history of severe liver disease.
  • Patients with history of stroke or uncontrolled hypertension
  • Inability to give informed consent
  • Pregnant patient

研究组 & 干预措施

Sumatriptan

Experimental

Subcutaneous injection of sumatriptan (6 mg)

干预措施: Sumatriptan (Drug)

Sumatriptan

Experimental

Subcutaneous injection of sumatriptan (6 mg)

干预措施: Placebo (Other)

Placebo

Placebo Comparator

Matching placebo (0.9% saline)

干预措施: Sumatriptan (Drug)

Placebo

Placebo Comparator

Matching placebo (0.9% saline)

干预措施: Placebo (Other)

结局指标

主要结局

Quality of Recovery

时间窗: 24 hours

Using the validated Quality of Recovery 40 Questionnaire (QoR-40)

次要结局

  • Post operative headache scores(24 hours)
  • Total analgesic consumption(24 hours)
  • Post operative pain scores(24 hours)
  • Postoperative nausea and vomiting(less than 24 hours)
  • Hospital discharge time(less than one week)
  • Time to first opioid administration(less than 24 hours)

研究者

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

Lashmi Venkatraghavan

Dr.

University Health Network, Toronto

研究点 (1)

Loading locations...

相似试验

Effect of Sumatriptan on the Postoperative Quality... | 临床试验