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Guanfacine for PONV and Pain After Sinus Surgery

Primary Purpose

Postoperative Nausea and Vomiting, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guanfacine
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Guanfacine

Placebo

Arm Description

Guanfacine 1 mg capsule by mouth, one time prior to surgery.

Placebo with a similar appearance to guanfacine by mouth one time prior to surgery

Outcomes

Primary Outcome Measures

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
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
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
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.

Secondary Outcome Measures

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
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
Total Narcotic Requirement in PACU
Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay
Number of Doses of PONV Treatment Administered in PACU
PACU Length of Stay in Minutes

Full Information

First Posted
July 15, 2016
Last Updated
December 13, 2018
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02882854
Brief Title
Guanfacine for PONV and Pain After Sinus Surgery
Official Title
Guanfacine for PONV and Pain After Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine
Arm Type
Experimental
Arm Description
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Intervention Description
Patients will receive 1 mg of guanfacine to take orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
Primary Outcome Measure Information:
Title
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Description
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
Time Frame
15 minutes after arriving in PACU
Title
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Description
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
Time Frame
30 minutes after arriving in PACU
Title
Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
Description
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
Time Frame
60 minutes after arriving in PACU
Title
Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)
Description
PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.
Time Frame
24 hours post op
Secondary Outcome Measure Information:
Title
Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
Description
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
Time Frame
15, 30, 60 minutes after arriving in PACU
Title
Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)
Description
Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain
Time Frame
24 hours postop
Title
Total Narcotic Requirement in PACU
Description
Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay
Time Frame
Time frame between arrival and discharge in PACU, approximately 90 minutes
Title
Number of Doses of PONV Treatment Administered in PACU
Time Frame
Time frame between arrival and discharge in PACU, approximately 90 minutes
Title
PACU Length of Stay in Minutes
Time Frame
Time frame between arrival and discharge in PACU, approximately 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen T Harvey, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Guanfacine for PONV and Pain After Sinus Surgery

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