Does a Pre-sedation Guided Visualization Exercise Improve Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery: a Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Anesthesia Experience Survey
研究概览
简要总结
This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups:
- A seven-point Anesthesia Experience Survey
- Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded
- Amount of medications used during the sedation
- Length of sedation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects within ages 8 to
- •Subjects planned for ambulatory intravenous sedation in the oral and maxillofacial surgery clinic.
- •Ability to understand verbal English or understand instructions using a sign-language or voice interpreter of their native language.
排除标准
- •Subjects who cannot understand the instructions, even with an interpreter (extremes of age, cognitive impairments, severe psychiatric disease that may affect participation)
- •Subjects not undergoing intravenous sedation (oral sedation, nitrous oxide, local anesthesia)
- •Subjects undergoing anesthesia in other environments (gastrointestinal suite, operating rooms, interventional radiology)
研究组 & 干预措施
Standardized pre-sedation instructions only group
This group will receive the standardized pre-sedation instructions only, with no guided visualization.
干预措施: Standardized pre-sedation instructions only (Behavioral)
Guided visualization and standardized pre-sedation instructions group
This arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.
干预措施: Guided visualization and standardized pre-sedation instructions (Behavioral)
结局指标
主要结局
Anesthesia Experience Survey
时间窗: Within 2 hours of the completion of surgery
A seven-point survey given after the patient meets Aldrete score discharge criteria, asking the following: how the patient rates their pre-operative anxiety level (0-10), if the patient has any recall of surgery (0 for none, 1 for a little, 2 for everything), if the patient remembers any pain during surgery (0 for none, 1 for a little, 2 for a lot), if the patient feels any nausea (0 for none, 1 for a little, 2 for a lot, 3 for vomiting), if the patient feels any pain now (0 for none, 1 for a little, 2 for a lot), if the patient feels any itching (0 for none, 1 for a little, 2 for a lot), and how satisfied the patient is overall with the sedation/anesthesia experience (0-10).
Face-Legs-Activity-Cry-Consolability (FLACC)
时间窗: During local anesthesia, during surgery, and fifteen minutes after surgery has concluded
Face-Legs-Activity-Cry-Consolability (FLACC) is a behavioral scale primarily designed for scoring postoperative pain in infants and young children, but can also be used to assess intraoperative and postoperative pain in adults undergoing intravenous sedation. The scale gives 0, 1, or 2 points for each of the following: the appearance of the patient's face, the appearance of the patient's legs, the amount of activity, the presence of crying, and the extent of consolability, for a total of 10 points. 0-3 points corresponds to mild pain, 4-6 to moderate pain, and 7-10 to severe pain. The scores will be taken at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded.
Amount of medications used during the sedation
时间窗: During the sedation
The amount of each medication utilized during the sedation will be documented.
Length of sedation
时间窗: During the sedation
The length of sedation will be measured, with the start point as the administration of the first sedative medication, and the endpoint as the end of phase I of anesthesia recovery, which will be determined with the Aldrete Scoring System.
次要结局
未报告次要终点
研究者
Omid Akramian
Resident Surgeon
Alameda Health System