Postoperative Nausea and VomitingNCT02882854
Guanfacine for PONV and Pain After Sinus Surgery
A study testing Guanfacine in people with Postoperative Nausea and Vomiting and Pain, Postoperative, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Pain, Postoperative
- What is being tested?
- Guanfacine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VUMC patients undergoing sinus surgery in MCE OR
Who cannot join
- Inability to read and freely consent
- Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine)
- Patients undergoing sinus surgery planned for greater than 3 hours
- Patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part
- Patients with preoperative nausea/vomiting at baseline.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.
Read the detailed description
Pain after surgery is commonly treated with narcotics which can potentiate PONV, further delaying PACU discharge. In multiple studies, alpha-2 agonists such as clonidine and dexmedetomidine reduce both the incidence of PONV and post-op pain, as well as requirements for postoperative analgesics. These actions are mediated via central alpha-2A receptors (A2AR). Of the A2AR agonists, guanfacine, though a weak antihypertensive agent, has the highest selectivity for the A2AR, but to date is untested for its potential to treat either PONV or post-operative pain.
- Being tested
- Guanfacine, Placebo
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
Patients will receive 1 mg of guanfacine to take orally.
PlaceboDrug
Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine | Experimental | Guanfacine 1 mg capsule by mouth, one time prior to surgery. Receives: Drug: Guanfacine |
| Placebo | Placebo comparator | Placebo with a similar appearance to guanfacine by mouth one time prior to surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Comparison of PONV Score of assessments done at 15 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Measured: 15 minutes after arriving in PACU
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Comparison of PONV Score of assessments done at 30 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Measured: 30 minutes after arriving in PACU
Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Comparison of PONV Score of assessments done at 60 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Measured: 60 minutes after arriving in PACU
Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)
PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.
Measured: 24 hours post op
Secondary outcomes (5)
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
Maximum postoperative pain assessment assessed in PACU at 15, 30 and 60 minutes after PACU arrival using VAS when 0 is no pain and 10 is worst pain
Measured: 15, 30, 60 minutes after arriving in PACU
Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain
Measured: 24 hours postop
Total Narcotic Requirement in PACU
Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay
Measured: Time frame between arrival and discharge in PACU, approximately 90 minutes
Number of Doses of PONV Treatment Administered in PACU
Measured: Time frame between arrival and discharge in PACU, approximately 90 minutes
PACU Length of Stay in Minutes
Measured: Time frame between arrival and discharge in PACU, approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Harvey, Vanderbilt University Medical Center
- Investigators
- Stephen T Harvey, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882854
- Sponsor's protocol ID
- 160282
- Status last verified
- Dec 2018
- First submitted
- 15 Jul 2016
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
PubMed 12402719Luttinger D, Ferrari R, Perrone MH, Haubrich DR. Pharmacological analysis of alpha-2 adrenergic mechanisms in nociception and ataxia. J Pharmacol Exp Ther. 1985 Mar;232(3):883-9.
PubMed 2857790Yamadera H, Ferber G, Matejcek M, Pokorny R. Electroencephalographic and psychometric assessment of the CNS effects of single doses of guanfacine hydrochloride (Estulic) and clonidine (Catapres). Neuropsychobiology. 1985;14(2):97-107. doi: 10.1159/000118212.
PubMed 3911096Connor DF, Arnsten AF, Pearson GS, Greco GF. Guanfacine extended release for the treatment of attention-deficit/hyperactivity disorder in children and adolescents. Expert Opin Pharmacother. 2014 Aug;15(11):1601-10. doi: 10.1517/14656566.2014.930437. Epub 2014 Jul 3.
PubMed 24992513Massad IM, Mohsen WA, Basha AS, Al-Zaben KR, Al-Mustafa MM, Alghanem SM. A balanced anesthesia with dexmedetomidine decreases postoperative nausea and vomiting after laparoscopic surgery. Saudi Med J. 2009 Dec;30(12):1537-41.
PubMed 19936416Kamibayashi T, Hayashi Y, Mammoto T, Yamatodani A, Sumikawa K, Yoshiya I. Role of the vagus nerve in the antidysrhythmic effect of dexmedetomidine on halothane/epinephrine dysrhythmias in dogs. Anesthesiology. 1995 Nov;83(5):992-9. doi: 10.1097/00000542-199511000-00013.
PubMed 7486186Unnerstall JR, Kopajtic TA, Kuhar MJ. Distribution of alpha 2 agonist binding sites in the rat and human central nervous system: analysis of some functional, anatomic correlates of the pharmacologic effects of clonidine and related adrenergic agents. Brain Res. 1984 Mar;319(1):69-101. doi: 10.1016/0165-0173(84)90030-4.
PubMed 6324960Giovannoni MP, Ghelardini C, Vergelli C, Dal Piaz V. Alpha2-agonists as analgesic agents. Med Res Rev. 2009 Mar;29(2):339-68. doi: 10.1002/med.20134.
PubMed 18680204Aghajanian GK, Wang YY. Common alpha 2- and opiate effector mechanisms in the locus coeruleus: intracellular studies in brain slices. Neuropharmacology. 1987 Jul;26(7B):793-9. doi: 10.1016/0028-3908(87)90054-2.
PubMed 2443865Ittermann T, Volzke H, Baumeister SE, Appel K, Grabe HJ. Diagnosed thyroid disorders are associated with depression and anxiety. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1417-25. doi: 10.1007/s00127-015-1043-0. Epub 2015 Mar 17.
PubMed 25777685Baser E, Togrul C, Ozgu E, Esercan A, Caglar M, Gungor T. Effect of pre-procedural state-trait anxiety on pain perception and discomfort in women undergoing colposcopy for cervical cytological abnormalities. Asian Pac J Cancer Prev. 2013;14(7):4053-6. doi: 10.7314/apjcp.2013.14.7.4053.
PubMed 23991951Benarroch EE. The locus ceruleus norepinephrine system: functional organization and potential clinical significance. Neurology. 2009 Nov 17;73(20):1699-704. doi: 10.1212/WNL.0b013e3181c2937c. No abstract available.
PubMed 19917994Goldman-Rakic PS. Cellular basis of working memory. Neuron. 1995 Mar;14(3):477-85. doi: 10.1016/0896-6273(95)90304-6. No abstract available.
PubMed 7695894Wang M, Gamo NJ, Yang Y, Jin LE, Wang XJ, Laubach M, Mazer JA, Lee D, Arnsten AF. Neuronal basis of age-related working memory decline. Nature. 2011 Jul 27;476(7359):210-3. doi: 10.1038/nature10243.
PubMed 21796118Goldman-Rakic PS. Circuitry of the frontal association cortex and its relevance to dementia. Arch Gerontol Geriatr. 1987 Sep;6(3):299-309. doi: 10.1016/0167-4943(87)90029-x.
PubMed 3318747
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guanfacine for PONV and Pain After Sinus Surgery
- ClinicalTrials.gov ID
- NCT02882854
- Acronym / sponsor ID
- 160282
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.
Detailed description
Pain after surgery is commonly treated with narcotics which can potentiate PONV, further delaying PACU discharge. In multiple studies, alpha-2 agonists such as clonidine and dexmedetomidine reduce both the incidence of PONV and post-op pain, as well as requirements for postoperative analgesics. These actions are mediated via central alpha-2A receptors (A2AR). Of the A2AR agonists, guanfacine, though a weak antihypertensive agent, has the highest selectivity for the A2AR, but to date is untested for its potential to treat either PONV or post-operative pain.
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 |
|---|---|---|
| Guanfacine | Experimental | Drug: GuanfacineGuanfacine 1 mg capsule by mouth, one time prior to surgery. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo with a similar appearance to guanfacine by mouth one time prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- VUMC patients undergoing sinus surgery in MCE OR
Key exclusion criteria (6 listed)
- Inability to read and freely consent
- Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine)
- Patients undergoing sinus surgery planned for greater than 3 hours
- Patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part
- Patients with preoperative nausea/vomiting at baseline.
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 |
|---|---|---|
| GuanfacinePatients will receive 1 mg of guanfacine to take orally. | Drug | Guanfacine |
| PlaceboPatients will receive a placebo containing no drug that appears similarly to guanfacine to take orally. | Drug | Placebo |
Primary outcome
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Time frame: 15 minutes after arriving in PACU
Comparison of PONV Score of assessments done at 15 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Time frame: 30 minutes after arriving in PACU
Comparison of PONV Score of assessments done at 30 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Time frame: 60 minutes after arriving in PACU
Comparison of PONV Score of assessments done at 60 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea
Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)
Time frame: 24 hours post op
PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.
5 secondary outcomes
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
Time frame: 15, 30, 60 minutes after arriving in PACU
Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
Time frame: 24 hours postop
Total Narcotic Requirement in PACU
Time frame: Time frame between arrival and discharge in PACU, approximately 90 minutes
Number of Doses of PONV Treatment Administered in PACU
Time frame: Time frame between arrival and discharge in PACU, approximately 90 minutes
PACU Length of Stay in Minutes
Time frame: Time frame between arrival and discharge in PACU, approximately 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12402719Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
- Background: PubMed 2857790Luttinger D, Ferrari R, Perrone MH, Haubrich DR. Pharmacological analysis of alpha-2 adrenergic mechanisms in nociception and ataxia. J Pharmacol Exp Ther. 1985 Mar;232(3):883-9.
- Background: PubMed 3911096Yamadera H, Ferber G, Matejcek M, Pokorny R. Electroencephalographic and psychometric assessment of the CNS effects of single doses of guanfacine hydrochloride (Estulic) and clonidine (Catapres). Neuropsychobiology. 1985;14(2):97-107. doi: 10.1159/000118212.
- Background: PubMed 24992513Connor DF, Arnsten AF, Pearson GS, Greco GF. Guanfacine extended release for the treatment of attention-deficit/hyperactivity disorder in children and adolescents. Expert Opin Pharmacother. 2014 Aug;15(11):1601-10. doi: 10.1517/14656566.2014.930437. Epub 2014 Jul 3.
- Background: PubMed 19936416Massad IM, Mohsen WA, Basha AS, Al-Zaben KR, Al-Mustafa MM, Alghanem SM. A balanced anesthesia with dexmedetomidine decreases postoperative nausea and vomiting after laparoscopic surgery. Saudi Med J. 2009 Dec;30(12):1537-41.
- Background: PubMed 7486186Kamibayashi T, Hayashi Y, Mammoto T, Yamatodani A, Sumikawa K, Yoshiya I. Role of the vagus nerve in the antidysrhythmic effect of dexmedetomidine on halothane/epinephrine dysrhythmias in dogs. Anesthesiology. 1995 Nov;83(5):992-9. doi: 10.1097/00000542-199511000-00013.
- Background: PubMed 6324960Unnerstall JR, Kopajtic TA, Kuhar MJ. Distribution of alpha 2 agonist binding sites in the rat and human central nervous system: analysis of some functional, anatomic correlates of the pharmacologic effects of clonidine and related adrenergic agents. Brain Res. 1984 Mar;319(1):69-101. doi: 10.1016/0165-0173(84)90030-4.
- Background: PubMed 18680204Giovannoni MP, Ghelardini C, Vergelli C, Dal Piaz V. Alpha2-agonists as analgesic agents. Med Res Rev. 2009 Mar;29(2):339-68. doi: 10.1002/med.20134.
- Background: PubMed 2443865Aghajanian GK, Wang YY. Common alpha 2- and opiate effector mechanisms in the locus coeruleus: intracellular studies in brain slices. Neuropharmacology. 1987 Jul;26(7B):793-9. doi: 10.1016/0028-3908(87)90054-2.
- Background: PubMed 25777685Ittermann T, Volzke H, Baumeister SE, Appel K, Grabe HJ. Diagnosed thyroid disorders are associated with depression and anxiety. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1417-25. doi: 10.1007/s00127-015-1043-0. Epub 2015 Mar 17.
- Background: PubMed 23991951Baser E, Togrul C, Ozgu E, Esercan A, Caglar M, Gungor T. Effect of pre-procedural state-trait anxiety on pain perception and discomfort in women undergoing colposcopy for cervical cytological abnormalities. Asian Pac J Cancer Prev. 2013;14(7):4053-6. doi: 10.7314/apjcp.2013.14.7.4053.
- Background: PubMed 19917994Benarroch EE. The locus ceruleus norepinephrine system: functional organization and potential clinical significance. Neurology. 2009 Nov 17;73(20):1699-704. doi: 10.1212/WNL.0b013e3181c2937c. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Stephen T Harvey, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guanfacine in people with Postoperative Nausea and Vomiting and Pain, Postoperative, run by Vanderbilt University Medical Center at 1 site in United States.
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 1 inclusion and 6 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 3 Jan 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS) (time frame: 15 minutes after arriving in PACU). The study lists 4 primary outcomes in all. 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 NCT02882854, which also lists 28 linked publications.
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 3 Jan 2019.