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

Condition(s) targeted: Basal Cell Carcinoma; Squamous Cell Carcinoma; Skin Cancer; Anxiety

Intervention: midazolam (Drug); Placebo (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Clark C Otley, MD, Principal Investigator, Affiliation: Mayo Clinic
Larisa Ravitskiy, MD, Principal Investigator, Affiliation: Mayo Clinic

Midazolam is an approved sedative medication used for medical procedures. This study is being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in the setting of Mohs micrographic surgery performed for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy. It also has beneficial effects on blood pressure, which may improve surgical results. These effects last for about 2 hours.

If you agree to be in the study and there exist no contraindications to your participation in this study, you will be asked to complete three brief questionnaires as well as have blood pressure and other vital signs checked during surgery. Participation in the study does not require a follow up visit, blood work, or other invasive procedures.

Official title: Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: visual analog scale anxiety assessment in randomized and prospective arms

Secondary outcome:

incidence of adverse events in randomized and prospective arms

vital signs (respiratory rate, heart rate, blood pressure) randomized and prospective arms

Detailed description: The main objective of this study is to establish the safety and efficacy of midazolam in patients with skin cancer undergoing outpatient Mohs micrographic surgery. Specifically, we will examine 124 patients 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 involves administration of midazolam in an unblinded fashion. Based on available studies of orally administered midazolam, the expectation is that the only observed adverse events will be minor and the major adverse event rate for midazolam will be similar to placebo. Data will be collected on vital signs, anxiety, adverse events, and overall satisfaction with the anxiolytic agent. Analysis of covariance (ANOCOVA) models with be fit to compare the outcome measures (e. g. visual analog scale (VAS) anxiety score at 60 minutes) between the two treatment arms, thereby allowing for the adjustment of the baseline VAS anxiety score and potential confounders (e. g., age and gender).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

18 years of age and older

1 or 2 sites of biopsy-confirmed squamous cell or basal cell carcinomas limited to head and neck regions

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 (more than a standard drink is equal to 13. 7 grams of pure alcohol or 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1. 5-ounces or a ?shot? of 80-proof distilled spirits or liquor) with 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 will be excluded as will patients on medications interfering with renal excretion or microsomal metabolism unless the last dose was taken; 5 half-lives55 prior to surgery as summarized in Table 1. Patients with weights less than 100 lb (45 kg) will be excluded as will 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.

RANDOMIZED ARM: Patients with a single cancer > 5 cm in the greatest dimension or with more than 2 cancers will be excluded. Patients who were previously premedicated with oral midazolam during prior MMS episodes will be excluded as well. Upper weight limit will be 220 lb (100 kg).

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. There will be no upper weight limitation.

Mayo Clinic, Rochester, Minnesota 55905, United States

Mayo Clinic Clinical Trials

Starting date: March 2007
Ending date: June 2008
Last updated: April 23, 2008