Guanfacine for PONV and Pain After Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VUMC patients undergoing sinus surgery in MCE OR
排除标准
- •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
研究组 & 干预措施
Guanfacine
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
干预措施: Guanfacine (Drug)
Placebo
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
时间窗: 30 minutes after arriving in PACU
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)
时间窗: 60 minutes after arriving in PACU
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
Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)
时间窗: 15 minutes after arriving in PACU
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
Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)
时间窗: 24 hours post op
PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.
次要结局
- 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)
- PACU Length of Stay in Minutes(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)
- Total Narcotic Requirement in PACU(Time frame between arrival and discharge in PACU, approximately 90 minutes)
研究者
Stephen Harvey
Assistant Professor
Vanderbilt University Medical Center