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Guanfacine for PONV and Pain After Sinus Surgery

Not Applicable
Completed
Conditions
Pain, Postoperative
Postoperative Nausea and Vomiting
Interventions
Drug: Placebo
Registration Number
NCT02882854
Lead Sponsor
Vanderbilt University Medical Center
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
84
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo with a similar appearance to guanfacine by mouth one time prior to surgery
GuanfacineGuanfacineGuanfacine 1 mg capsule by mouth, one time prior to surgery.
Primary Outcome Measures
NameTimeMethod
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)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)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

Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)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

Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)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
NameTimeMethod
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)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

Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)24 hours postop

Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain

PACU Length of Stay in MinutesTime frame between arrival and discharge in PACU, approximately 90 minutes
Number of Doses of PONV Treatment Administered in PACUTime frame between arrival and discharge in PACU, approximately 90 minutes
Total Narcotic Requirement in PACUTime frame between arrival and discharge in PACU, approximately 90 minutes

Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay

Trial Locations

Locations (1)

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

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