Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery

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.

Inclusion criteria

• 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

Exclusion criteria

• 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)