Guanfacine for PONV and Pain After Sinus Surgery

Study Overview
=================
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.

Official Title
-----------------
Guanfacine for PONV and Pain After Sinus Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting, Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Guanfacine
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guanfacine<br>Guanfacine 1 mg capsule by mouth, one time prior to surgery. | Drug: Guanfacine<br>* Patients will receive 1 mg of guanfacine to take orally.<br>|
| Placebo Comparator: Placebo<br>Placebo with a similar appearance to guanfacine by mouth one time prior to surgery | Drug: Placebo<br>* Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.<br>|

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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 between arrival and discharge in PACU, approximately 90 minutes | 
| PACU Length of Stay in Minutes |  | Time frame between arrival and discharge in PACU, approximately 90 minutes |