Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo
研究概览
简要总结
This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.
详细描述
Primary Objective:
To compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo.
Secondary Objective:
To evaluate the following secondary outcomes:
- Anxiety score (HADS) in preoperative holding area
- Midazolam use intraoperatively (mg)
- Itraoperative opioid use (morphine equivalents)
- Intraoperative anti-emetic use
- Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
- Rate and intensity of PONV in PACU
- Antiemetic use in PACU
- Opioid use in PACU (morphine equivalents)
- Pain intensity in PACU (0-10 numerical rating scale)
- Patient satisfaction in PACU
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult patients (≥ 18 years old)
- •Port-a-Cath placement under Monitored Anesthesia Care
- •Signed informed consent
排除标准
- •Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device)
- •Patients requiring general anesthesia or those not eligible for MAC
结局指标
主要结局
To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo
时间窗: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average
It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready
次要结局
- Anxiety Score (HADS) in Preoperative Holding Area(From "In preop" to "Preop end" per EMR. 1hr in average)
- Midazolam Use Intraoperatively (mg)(From "Anesthesia Start" to "Anesthesia End". 1hr in average)
- Opioid Use Intraoperatively (in MEDD)(From "Anesthesia Start" to "Anesthesia End". 1hr in average)
- Intraoperative Anti-emetic Use(From "Anesthesia Start" to "Anesthesia End". 1hr in average)
- Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU(From "PACU Start" to "PACU Discharge", 1.5 hr in average)
- Rate and Intensity of PONV in PACU(From "PACU Start" to "PACU Discharge", 1.5 hr in average)
- Anti-emetic Use in PACU(From "PACU Start" to "PACU Discharge", 1.5 hr in average)
- Opioid Use in PACU(From "PACU Start" to "PACU Discharge", 1.5 hr in average)
- Pain Intensity in PACU (0-10 Numerical Rating Scale)(From "PACU Start" to "PACU Discharge", 1.5 hr in average)
- Patient Satisfaction in PACU(From "PACU Start" to "PACU Discharge", 1.5 hr in average)