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

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ClinicalTrials.gov Identifier: NCT01632657
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Lashmi Venkatraghavan, University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Quality of Recovery Postoperative Migrainous Headache Drug: Sumatriptan Other: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
Study Start Date : June 2012
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Experimental: Elective craniotomy and clipping of intracranial aneurysm
Subcutaneous injection of sumatriptan (6 mg)
Drug: Sumatriptan
Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery

Other: Placebo
Single injection saline 0.5ml subcutaneously in recovery

Placebo Comparator: Elective craniotomy and microvascular decompression
Matching placebo (0.9% saline)
Drug: Sumatriptan
Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery

Other: Placebo
Single injection saline 0.5ml subcutaneously in recovery




Primary Outcome Measures :
  1. Quality of Recovery [ Time Frame: 24 hours ]
    Using the validated Quality of Recovery 40 Questionnaire (QoR-40)


Secondary Outcome Measures :
  1. Post operative pain scores [ Time Frame: 24 hours ]
    Surgical site pain scores reported in the PACU. The numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable) validated for measuring postoperative pain intensity. This scale is often used to divide patients into groups who are in need of pain treatment (moderate and severe pain) and those who are not (mild pain).

  2. Post operative headache scores [ Time Frame: 24 hours ]
    The Migraine-Specific Symptoms and Disability criteria and the Migraine Headache Index are used to characterize migraine symptoms in patient population before and after decompressive surgery.

  3. Total analgesic consumption [ Time Frame: 24 hours ]
    Postoperative analgesic consumption will be assessed in the two groups

  4. Time to first opioid administration [ Time Frame: less than 24 hours ]
    Monitoring the time of the first opioid dose in recovery room

  5. Postoperative nausea and vomiting [ Time Frame: less than 24 hours ]
    The incidence of PONV throughout the postoperative period

  6. Hospital discharge time [ Time Frame: less than one week ]
    Time to hospital discharge is recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients having elective craniotomy for clipping of unruptured intracranial aneurysm
  2. Patients having craniotomy and microvascular decompression for cranial nerve neuralgia
  3. Age 18-80
  4. ASA I -III

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632657


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Lashmi Venkatraghavan, MD University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lashmi Venkatraghavan, Dr., University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01632657    
Other Study ID Numbers: 12-0139-B
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Pain
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs