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Guanfacine for PONV and Pain After Sinus Surgery

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ClinicalTrials.gov Identifier: NCT02882854
Recruitment Status : Completed
First Posted : August 30, 2016
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Harvey, Vanderbilt University Medical Center

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Pain, Postoperative Drug: Guanfacine Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Guanfacine for PONV and Pain After Sinus Surgery
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Guanfacine
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
 Drug: Guanfacine
Patients will receive 1 mg of guanfacine to take orally.
Placebo Comparator: Placebo
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
 Drug: Placebo
Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS) [ Time Frame: 15, 30, 60 minutes after arriving in PACU ]
    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

  2. Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS) [ Time Frame: 24 hours postop ]
    Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain

  3. Total Narcotic Requirement in PACU [ Time Frame: Time frame between arrival and discharge in PACU, approximately 90 minutes ]
    Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay

  4. Number of Doses of PONV Treatment Administered in PACU [ Time Frame: Time frame between arrival and discharge in PACU, approximately 90 minutes ]
  5. PACU Length of Stay in Minutes [ Time Frame: Time frame between arrival and discharge in PACU, approximately 90 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VUMC patients undergoing sinus surgery in MCE OR

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882854


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Stephen T Harvey, MD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Stephen Harvey, Vanderbilt University Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] March 10, 2016

More Information
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Publications:

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Responsible Party: Stephen Harvey, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02882854    
Other Study ID Numbers: 160282
First Posted: August 30, 2016    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs