Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
February 9, 2012
CompletedFebruary 9, 2012
February 1, 2012
1.1 years
December 20, 2007
January 13, 2012
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Anxiety at Baseline
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).
Baseline (prior to drug administration)
Patient Anxiety at 60 and 120 Minutes
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).
60 and 120 minutes after drug administration
Secondary Outcomes (12)
Patient Alertness at Baseline
Baseline (prior to drug administration)
Patient Alertness at 60 and 120 Minutes
60 and 120 minutes after drug administration
Patient Cognitive Function at Baseline and 60 Minutes
baseline (prior to drug administration) and 60 minutes after drug administration
Patient Cognitive Function at 120 Minutes
120 minutes after drug administration
Blood Pressure at 30 Minutes
30 minutes after drug administration
- +7 more secondary outcomes
Study Arms (3)
Randomized Midazolam
ACTIVE COMPARATORSingle-dose midazolam
Placebo
PLACEBO COMPARATORProspective Midazolam
EXPERIMENTALInterventions
Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup.
The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
Lidocaine 1% with 1:100,000 epinephrine
Midazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (\>45 to 77 kg, 10 mg; \>77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis.
Eligibility Criteria
You may qualify if:
- \- 1 or 2 sites of biopsy-confirmed squamous cell or basal cell carcinomas limited to head and neck regions
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Ravitskiy L, Phillips PK, Roenigk RK, Weaver AL, Killian JM, Hoverson Schott A, Otley CC. The use of oral midazolam for perioperative anxiolysis of healthy patients undergoing Mohs surgery: conclusions from randomized controlled and prospective studies. J Am Acad Dermatol. 2011 Feb;64(2):310-22. doi: 10.1016/j.jaad.2010.02.038.
PMID: 21238825RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was hindered by slow accrual and fell short of reaching the target number of patients.
Results Point of Contact
- Title
- Dr. Clark C. Otley
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Clark C Otley, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Larisa Ravitskiy, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 21, 2007
Study Start
March 1, 2007
Primary Completion
April 1, 2008
Study Completion
June 1, 2008
Last Updated
February 9, 2012
Results First Posted
February 9, 2012
Record last verified: 2012-02