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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 : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Lashmi Venkatraghavan, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE July 3, 2012
Last Update Posted Date October 10, 2018
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Quality of Recovery [ Time Frame: 24 hours ]
Using the validated Quality of Recovery 40 Questionnaire (QoR-40)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
Official Title  ICMJE Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Quality of Recovery
  • Postoperative Migrainous Headache
Intervention  ICMJE
  • Drug: Sumatriptan
    Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery
  • Drug: Placebo
    Single injection saline 0.5ml subcutaneously in recovery
Study Arms  ICMJE
  • Elective craniotomy and clipping of intracranial aneurysm
    Interventions:
    • Drug: Sumatriptan
    • Drug: Placebo
  • Elective craniotomy and microvascular decompression
    Interventions:
    • Drug: Sumatriptan
    • Drug: Placebo
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2019
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lashmi Venkatraghavan, MD 4166035118 lashmi.venkatraghavan@uhn.ca
Contact: Jigesh Mehta, MD 6476318264 jigesh.mehta@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632657
Other Study ID Numbers  ICMJE 12-0139-B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lashmi Venkatraghavan, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date October 2018

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