Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Patient Anxiety at Baseline
研究概览
简要总结
Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2 hours.
This study had two parts. In the first part, eligible patients were randomized to either receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with neither the patient nor the study team knowing which patient received the study drug. In the second part, patients who were not eligible to participate in the randomized study or who refused to participate in the randomized study were enrolled in a prospective arm where they knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the patient's weight, and patients were given additional doses of midazolam syrup as necessary to control their anxiety.
The primary hypothesis of this study was that a single dose of oral midazolam syrup to patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis of this study was that patients given oral midazolam would have the rate of adverse events that was not worse than 25% higher than in the placebo group.
详细描述
The main objective of this study was to establish the safety and efficacy of midazolam in patients with skin cancer undergoing outpatient Mohs micrographic surgery. Patients were randomized in a double-blind placebo-controlled study of a single-dose midazolam syrup for efficacy in producing safe anxiolysis of short duration. A parallel prospective arm of the study involved administration of midazolam in an unblinded fashion. Based on available studies of orally administered midazolam, the expectation was that the only observed adverse events will be minor and the major adverse event rate for midazolam would be similar to placebo. Data was collected on vital signs, anxiety, adverse events, and overall satisfaction with the anxiolytic agent.
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
- •1 or 2 sites of biopsy-confirmed squamous cell or basal cell carcinomas limited to head and neck regions
- •Inclusion Criteria for Prospective Arm:
- •Patients wishing to receive oral midazolam in a non-blinded fashion will not be excluded based on the size of an individual tumor, total number of tumors, or prior history of oral midazolam
- •No upper weight limitation
排除标准
- •Prior history of allergy to midazolam or any of the syrup components
- •History of hypersensitivity to other benzodiazepines
- •Congestive heart failure (AHA Class III and IV)
- •Renal failure requiring hemodialysis
- •End-stage liver failure
- •Chronic alcoholism or alcohol intoxication within 24 hours of surgery
- •Untreated or uncontrolled open angle glaucoma
- •Uncontrolled hypertension
- •History of psychoses or affective disorders
- •Neuromuscular disorders such as myasthenia gravis
- •Chronic obstructive pulmonary disease
- •Patients on medications interfering with renal excretion or microsomal metabolism unless the last dose was taken greater than or equal to 5 half-lives prior to surgery
- •Patients weighing less than 100 lb (45 kg)
- •Pregnant women; women of childbearing potential will be required to take an in-office urine pregnancy test.
- •Breast-feeding mothers must stop breast-feeding for 7 days after taking midazolam to take part in this study
- •Additional Exclusion Criteria for Randomized Arms:
- •Patients with a single cancer > 5 cm in the greatest dimension or with more than 2 cancers
- •Patients who were previously premedicated with oral midazolam during prior Mohs micrographic surgery episodes
- •Patients weighing more than 220 lb (100 kg)
研究组 & 干预措施
Randomized Midazolam
Single-dose midazolam
干预措施: Randomized Midazolam (Drug)
Randomized Midazolam
Single-dose midazolam
干预措施: Local Anesthesia (Drug)
Placebo
干预措施: Placebo (Other)
Placebo
干预措施: Local Anesthesia (Drug)
Prospective Midazolam
干预措施: Local Anesthesia (Drug)
Prospective Midazolam
干预措施: Prospective Midazolam (Drug)
结局指标
主要结局
Patient Anxiety at Baseline
时间窗: Baseline (prior to drug administration)
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
Patient Anxiety at 60 and 120 Minutes
时间窗: 60 and 120 minutes after drug administration
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
次要结局
- Patient Alertness at Baseline(Baseline (prior to drug administration))
- Patient Alertness at 60 and 120 Minutes(60 and 120 minutes after drug administration)
- Patient Cognitive Function at Baseline and 60 Minutes(baseline (prior to drug administration) and 60 minutes after drug administration)
- Patient Cognitive Function at 120 Minutes(120 minutes after drug administration)
- Blood Pressure at 30 Minutes(30 minutes after drug administration)
- Heart Rate at 30 Minutes(30 minutes after drug administration)
- Respiratory Rate at 30 Minutes(30 minutes after drug administration)
- Pulse Oximetry at 30 Minutes(30 minutes after drug administration)
- Blood Pressure at 60 Minutes(60 minutes after drug administration)
- Heart Rate at 60 Minutes(60 minutes after drug administration)
- Respiratory Rate at 60 Minutes(60 minutes after drug administration)
- Pulse Oximetry at 60 Minutes(60 minutes after drug administration)