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

NCT01632657 | Completed DMC

• 1 other identifier: 12-0139
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Quality of Recovery; Postoperative Migrainous Headache

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  Using the validated Quality of Recovery 40 Questionnaire (QoR-40)

  24 hours

Secondary Outcomes (6)

• Post operative pain scores

  24 hours

• Post operative headache scores

  24 hours

• Total analgesic consumption

  24 hours

• Time to first opioid administration

  less than 24 hours

• Postoperative nausea and vomiting

  less than 24 hours

Study Arms (2)

Sumatriptan

EXPERIMENTAL

Subcutaneous injection of sumatriptan (6 mg)

Drug: Sumatriptan; Other: Placebo

Placebo

PLACEBO COMPARATOR

Matching placebo (0.9% saline)

Drug: Sumatriptan; Other: Placebo

Interventions

Sumatriptan DRUG

Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery

Placebo; Sumatriptan

Placebo OTHER

Single injection saline 0.5ml subcutaneously in recovery

Placebo; Sumatriptan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having elective craniotomy for clipping of unruptured intracranial aneurysm
• Patients having craniotomy and microvascular decompression for cranial nerve neuralgia
• Age 18-80
• ASA I -III

You may not qualify if:

• Patients with a known history of hypersensitivity to Sumatriptan or sulphonamides
• Patients with a known history of Migraine
• Patients who is on regular treatment with Sumatriptan
• Patients with history of Ischemic heart disease - Angina, Myocardial infarction.
• Patients who had rupture of their intracranial aneurysm.
• Patients with history of severe liver disease.
• Patients with history of stroke or uncontrolled hypertension
• Inability to give informed consent
• Pregnant patient

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27317706 DERIVED

MeSH Terms

Interventions

Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lashmi Venkatraghavan, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: October 15, 2019
• Study Completion: December 15, 2019
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

CA (1)