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Completed

NCT Number: NCT02882854

Guanfacine for PONV and Pain After Sinus Surgery

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guanfacine

Drug

Patients will receive 1 mg of guanfacine to take orally.

Placebo

Drug

Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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