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Guanfacine for PONV and Pain After Sinus Surgery

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Postoperative Nausea and Vomiting
Pain, Postoperative

Treatments

Drug: Guanfacine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 2 patient groups, including a placebo group

Guanfacine
Experimental group
Description:
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Treatment:
Drug: Guanfacine
Placebo
Placebo Comparator group
Description:
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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