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

This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01632657
First received: June 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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 Intervention
Postoperative Quality of Recovery
Postoperative Migrainous Headache
 Drug: Sumatriptan
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Quality of Recovery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Using the validated Quality of Recovery 40 Questionnaire (QoR-40)


Secondary Outcome Measures:
  • Post operative pain scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Post operative headache scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Total analgesic consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to first opioid administration [ Time Frame: less than 24 hours ] [ Designated as safety issue: No ]
  • Postoperative nausea and vomiting [ Time Frame: less than 24 hours ] [ Designated as safety issue: No ]
  • Post operative sedation [ Time Frame: less than 24 hours ] [ Designated as safety issue: No ]
  • Hospital discharge time [ Time Frame: less than one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: June 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632657

Contacts
Contact: Lashmi Venkatraghavan, MD 4166035118 lashmi.venkatraghavan@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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01632657     History of Changes
Other Study ID Numbers: 12-01390-B
Study First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: Canada: UHN Research Ethics Board

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013