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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 May 2016 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632657
First Posted: July 3, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
June 28, 2012
July 3, 2012
May 12, 2016
June 2012
June 2017   (Final data collection date for primary outcome measure)
Quality of Recovery [ Time Frame: 24 hours ]
Using the validated Quality of Recovery 40 Questionnaire (QoR-40)
Same as current
Complete list of historical versions of study NCT01632657 on ClinicalTrials.gov Archive Site
  • Post operative pain scores [ Time Frame: 24 hours ]
  • Post operative headache scores [ Time Frame: 24 hours ]
  • Total analgesic consumption [ Time Frame: 24 hours ]
  • Time to first opioid administration [ Time Frame: less than 24 hours ]
  • Postoperative nausea and vomiting [ Time Frame: less than 24 hours ]
  • Post operative sedation [ Time Frame: less than 24 hours ]
  • Hospital discharge time [ Time Frame: less than one week ]
Same as current
Not Provided
Not Provided
 
Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Quality of Recovery
  • Postoperative Migrainous Headache
  • 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 clipping of intracranial aneurysm
    Interventions:
    • Drug: Sumatriptan
    • Drug: Placebo
  • Elective craniotomy and microvascular decompression
    Interventions:
    • Drug: Sumatriptan
    • Drug: Placebo
Venkatraghavan L, Li L, Bailey T, Manninen PH, Tymianski M. Sumatriptan improves postoperative quality of recovery and reduces postcraniotomy headache after cranial nerve decompression. Br J Anaesth. 2016 Jul;117(1):73-9. doi: 10.1093/bja/aew152.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
June 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Lashmi Venkatraghavan, MD 4166035118 lashmi.venkatraghavan@uhn.ca
Contact: Jigesh Mehta, MD 6476318264 jigesh.mehta@uhn.ca
Canada
 
 
NCT01632657
12-0139-B
Yes
Not Provided
Not Provided
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP