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


N/A
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer, Anxiety

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Trial Information

Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Patient Anxiety at Baseline

Outcome Description:

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).

Outcome Time Frame:

Baseline (prior to drug administration)

Safety Issue:

No

Principal Investigator

Clark C Otley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

07-000848

NCT ID:

NCT00578214

Start Date:

March 2007

Completion Date:

June 2008

Related Keywords:

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Skin Cancer
  • Anxiety
  • mohs micrographic surgery
  • skin cancer
  • anxiety
  • basal cell carcinoma
  • squamous cell carcinoma
  • midazolam
  • versed
  • Anxiety Disorders
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell

Name

Location

Mayo Clinic Rochester, Minnesota  55905