Guanfacine for PONV and Pain After Sinus Surgery

NCT02882854 | Completed Results

• 1 other identifier: 160282
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)

  15, 30, 60 minutes after arriving in PACU

• Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)

  24 hours postop

• Total Narcotic Requirement in PACU

  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

Study Arms (2)

Guanfacine

EXPERIMENTAL

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

Drug: Guanfacine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Guanfacine DRUG

Patients will receive 1 mg of guanfacine to take orally.

Guanfacine

Placebo DRUG

Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VUMC patients undergoing sinus surgery in MCE OR

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Stephen Harvey, MD
• Organization: Vanderbilt University Medical Center

stephen.harvey@vumc.org

(615) 936-3198

Study Officials

• Stephen T Harvey, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 30, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 3, 2019
• Results First Posted: January 3, 2019

Record last verified: 2018-12

Locations

US (1)