Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
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.