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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 : Recruiting
First Posted : July 3, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Patients with unruptured brain aneurysms and pain syndromes like trigeminal neuralgias often undergo minimally invasive brain surgery with a smaller incision,shorter duration of procedure and in some patients the possibility of going home on same day. Postoperative pain, nausea and vomiting are sometimes difficult to manage with conventional medications. This affects recovery from surgery and often delays discharge from the hospital. This study looks at the use of a medication called sumatriptan which is a drug that has been used in the treatment of migraine headaches for a very long time. This drug works on the receptors in the lining of the brain and around the nerves which maybe associated with pain. The purpose of this study is to determine if this pain medication sumatriptan given at the end of the surgery improves the postoperative course in terms of less pain, less nausea and vomiting and generally having a better postoperative quality of recovery.

Our main hypothesis is that subcutaneous sumatriptan (6mg) administered at the end of surgery will improve the postoperative quality of recovery at 24 hours after elective minimally invasive craniotomies.


Condition or disease Intervention/treatment
Postoperative Quality of Recovery Postoperative Migrainous Headache Drug: Sumatriptan Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 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
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Sumatriptan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Elective craniotomy and clipping of intracranial aneurysm Drug: Sumatriptan
Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery
Drug: Placebo
Single injection saline 0.5ml subcutaneously in recovery
Elective craniotomy and microvascular decompression Drug: Sumatriptan
Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery
Drug: Placebo
Single injection saline 0.5ml subcutaneously in recovery


Outcome Measures

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 ]
  2. Post operative headache scores [ Time Frame: 24 hours ]
  3. Total analgesic consumption [ Time Frame: 24 hours ]
  4. Time to first opioid administration [ Time Frame: less than 24 hours ]
  5. Postoperative nausea and vomiting [ Time Frame: less than 24 hours ]
  6. Post operative sedation [ Time Frame: less than 24 hours ]
  7. Hospital discharge time [ Time Frame: less than one week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Lashmi Venkatraghavan, MD 4166035118 lashmi.venkatraghavan@uhn.ca
Contact: Jigesh Mehta, MD 6476318264 jigesh.mehta@uhn.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Lashmi Venkatraghavav, MD    4166035118    lashmi.venkatraghavan@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01632657     History of Changes
Other Study ID Numbers: 12-0139-B
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central 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