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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

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE July 3, 2012
Last Update Posted Date May 24, 2021
Study Start Date  ICMJE June 2012
Actual 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: May 19, 2021)
  • 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).
  • 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.
  • Total analgesic consumption [ Time Frame: 24 hours ]
    Postoperative analgesic consumption will be assessed in the two groups
  • Time to first opioid administration [ Time Frame: less than 24 hours ]
    Monitoring the time of the first opioid dose in recovery room
  • Postoperative nausea and vomiting [ Time Frame: less than 24 hours ]
    The incidence of PONV throughout the postoperative period
  • Hospital discharge time [ Time Frame: less than one week ]
    Time to hospital discharge is recorded.
Original 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 ]
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 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.
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.
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
  • Other: Placebo
    Single injection saline 0.5ml subcutaneously in recovery
Study Arms  ICMJE
  • Experimental: Elective craniotomy and clipping of intracranial aneurysm
    Subcutaneous injection of sumatriptan (6 mg)
    Interventions:
    • Drug: Sumatriptan
    • Other: Placebo
  • Placebo Comparator: Elective craniotomy and microvascular decompression
    Matching placebo (0.9% saline)
    Interventions:
    • Drug: Sumatriptan
    • Other: 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2021)
40
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
92
Actual Study Completion Date  ICMJE December 15, 2019
Actual 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 information is only displayed when the study is recruiting subjects
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
Principal Investigator: Lashmi Venkatraghavan, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2021

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