Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Basal Cell Carcinoma; Squamous Cell Carcinoma; Skin Cancer; Anxiety
Intervention: Randomized Midazolam (Drug); Placebo (Other); Local Anesthesia (Drug); Prospective Midazolam (Drug)
Phase: N/A
Status: Completed
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
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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Patient Anxiety at BaselinePatient Anxiety at 60 and 120 Minutes
Secondary outcome: Patient Alertness at BaselinePatient Alertness at 60 and 120 Minutes Patient Cognitive Function at Baseline and 60 Minutes Patient Cognitive Function at 120 Minutes Blood Pressure at 30 Minutes Heart Rate at 30 Minutes Respiratory Rate at 30 Minutes Pulse Oximetry at 30 Minutes Blood Pressure at 60 Minutes Heart Rate at 60 Minutes Respiratory Rate at 60 Minutes Pulse Oximetry at 60 Minutes
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Mayo Clinic Clinical Trials
Starting date: March 2007
Last updated: February 8, 2012
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