Guanfacine for PONV and Pain After Sinus Surgery

December 13, 2018 updated by: Stephen Harvey, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
60 minutes after arriving in PACU
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.
24 hours post op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15, 30, 60 minutes after arriving in PACU
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
24 hours postop
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
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
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
Time frame between arrival and discharge in PACU, approximately 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Stephen T Harvey, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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