Postoperative Quality of RecoveryNCT01632657
Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
A study testing Sumatriptan in people with Postoperative Quality of Recovery and Postoperative Migrainous Headache, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Quality of Recovery, Postoperative Migrainous Headache
- What is being tested?
- Sumatriptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Patients with history of stroke or uncontrolled hypertension
- Inability to give informed consent
- Pregnant patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Sumatriptan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumatriptanDrug
Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery
PlaceboOther
Single injection saline 0.5ml subcutaneously in recovery
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan | Experimental | Subcutaneous injection of sumatriptan (6 mg) Receives: Drug: Sumatriptan; Other: Placebo |
| Placebo | Placebo comparator | Matching placebo (0.9% saline) Receives: Drug: Sumatriptan; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Using the validated Quality of Recovery 40 Questionnaire (QoR-40)
Measured: 24 hours
Secondary outcomes (6)
Post operative pain scores
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).
Measured: 24 hours
Post operative headache scores
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.
Measured: 24 hours
Total analgesic consumption
Postoperative analgesic consumption will be assessed in the two groups
Measured: 24 hours
Time to first opioid administration
Monitoring the time of the first opioid dose in recovery room
Measured: less than 24 hours
Postoperative nausea and vomiting
The incidence of PONV throughout the postoperative period
Measured: less than 24 hours
Hospital discharge time
Time to hospital discharge is recorded.
Measured: less than one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJun 2012
- Primary completion15 Oct 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- Lashmi Venkatraghavan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632657
- Sponsor's protocol ID
- 12-0139
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2012
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27317706
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
- ClinicalTrials.gov ID
- NCT01632657
- Acronym / sponsor ID
- 12-0139
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan | Experimental | Drug: Sumatriptan, Other: PlaceboSubcutaneous injection of sumatriptan (6 mg) |
| Placebo | Placebo comparator | Drug: Sumatriptan, Other: PlaceboMatching placebo (0.9% saline) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SumatriptanSingle subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery | Drug | Placebo, Sumatriptan |
| PlaceboSingle injection saline 0.5ml subcutaneously in recovery | Other | Placebo, Sumatriptan |
Primary outcome
Quality of Recovery
Time frame: 24 hours
Using the validated Quality of Recovery 40 Questionnaire (QoR-40)
6 secondary outcomes
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
Hospital discharge time
Time frame: less than one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 27317706Venkatraghavan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lashmi Venkatraghavan, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sumatriptan in people with Postoperative Quality of Recovery and Postoperative Migrainous Headache, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.