Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)
研究概览
简要总结
Our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. The main outcome of this study will be patient satisfaction with the medication and analgesia. Secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:
- •Skin lesion excision or reconstruction
- •Fine or core needle aspiration biopsy
- •Mucosal biopsy
- •Laryngeal injection or biopsy
- •Myringotomy with or without tympanostomy tube insertion
- •Inferior turbinate reduction
- •Septal button insertion
排除标准
- •Patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)
- •Presence of any contraindications to inhaled methoxyfluorane per product monograph:
- •Patients less than 18 years of age
- •Pregnancy, intended pregnancy, or current breast-feeding
- •Inadequate patient understanding or lack of cooperation
- •Decreased level of consciousness or head injury
- •History of clinically significant renal impairment, e.g., reduced renal output
- •History of liver dysfunction following previous exposure to halogenated anesthetics
- •Current use of tetracycline antibiotics
- •Personal or genetic history of malignant hyperthermia
- •Muscular dystrophy
研究组 & 干预措施
Patients undergoing an otolaryngology in-office procedure using methoxyflurane
All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:
- Skin lesion excision or reconstruction
- Fine or core needle aspiration biopsy
- Mucosal biopsy
- Laryngeal injection or biopsy
- Myringotomy with or without tympanostomy tube insertion
- Inferior turbinate reduction
- Septal button insertion
干预措施: Methoxyflurane anesthesia (Drug)
结局指标
主要结局
TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)
时间窗: At first follow-up visit (within 1 month post-procedure)
This is a validated 14-item including Likert scales and dichotomous (yes/no) items on the effectiveness, side effects, convenience and global satisfaction with the medication taken
次要结局
- Modified Ramsay Sedation score(At procedure visit)
- Adverse events(At procedure visit and first follow-up visit (within 1 month post-procedure))
- Visual analog pain scale(At procedure visit)
- Ability to complete intended procedure(At procedure visit)