Clinical trial NCT02882854: Guanfacine for PONV and Pain After Sinus Surgery
Official title: Guanfacine for PONV and Pain After Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Pain, Postoperative
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
timeFrame: 15 minutes after arriving in PACU
measure: Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
timeFrame: 30 minutes after arriving in PACU
measure: Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
timeFrame: 60 minutes after arriving in PACU
measure: Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)
timeFrame: 24 hours post op
Secondary outcomes:
measure: Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
timeFrame: 15, 30, 60 minutes after arriving in PACU
measure: Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
timeFrame: 24 hours postop
measure: Total Narcotic Requirement in PACU
timeFrame: Time frame between arrival and discharge in PACU, approximately 90 minutes
measure: Number of Doses of PONV Treatment Administered in PACU
timeFrame: Time frame between arrival and discharge in PACU, approximately 90 minutes
measure: PACU Length of Stay in Minutes
timeFrame: Time frame between arrival and discharge in PACU, approximately 90 minutes
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Stephen T Harvey, MD
role: PRINCIPAL_INVESTIGATOR
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