Back to resultsSafety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
Primary Purpose
Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomized Midazolam
Placebo
Local Anesthesia
Prospective Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring mohs micrographic surgery, skin cancer, anxiety, basal cell carcinoma, squamous cell carcinoma, midazolam, versed
Eligibility 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)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
Randomized Midazolam
Placebo
Prospective Midazolam
Arm Description
Single-dose midazolam
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Patient Alertness at Baseline
A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).
Patient Alertness at 60 and 120 Minutes
A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).
Patient Cognitive Function at Baseline and 60 Minutes
Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).
Patient Cognitive Function at 120 Minutes
Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).
Blood Pressure at 30 Minutes
Heart Rate at 30 Minutes
Respiratory Rate at 30 Minutes
Pulse Oximetry at 30 Minutes
Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.
Blood Pressure at 60 Minutes
Heart Rate at 60 Minutes
Respiratory Rate at 60 Minutes
Pulse Oximetry at 60 Minutes
Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00578214
Brief Title
Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
Official Title
Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer, Anxiety
Keywords
mohs micrographic surgery, skin cancer, anxiety, basal cell carcinoma, squamous cell carcinoma, midazolam, versed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomized Midazolam
Arm Type
Active Comparator
Arm Description
Single-dose midazolam
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Prospective Midazolam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Randomized Midazolam
Other Intervention Name(s)
Versed
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
Intervention Type
Drug
Intervention Name(s)
Local Anesthesia
Intervention Description
Lidocaine 1% with 1:100,000 epinephrine
Intervention Type
Drug
Intervention Name(s)
Prospective Midazolam
Other Intervention Name(s)
Versed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Anxiety at Baseline
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).
Time Frame
Baseline (prior to drug administration)
Title
Patient Anxiety at 60 and 120 Minutes
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).
Time Frame
60 and 120 minutes after drug administration
Secondary Outcome Measure Information:
Title
Patient Alertness at Baseline
Description
A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).
Time Frame
Baseline (prior to drug administration)
Title
Patient Alertness at 60 and 120 Minutes
Description
A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).
Time Frame
60 and 120 minutes after drug administration
Title
Patient Cognitive Function at Baseline and 60 Minutes
Description
Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).
Time Frame
baseline (prior to drug administration) and 60 minutes after drug administration
Title
Patient Cognitive Function at 120 Minutes
Description
Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).
Time Frame
120 minutes after drug administration
Title
Blood Pressure at 30 Minutes
Time Frame
30 minutes after drug administration
Title
Heart Rate at 30 Minutes
Time Frame
30 minutes after drug administration
Title
Respiratory Rate at 30 Minutes
Time Frame
30 minutes after drug administration
Title
Pulse Oximetry at 30 Minutes
Description
Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.
Time Frame
30 minutes after drug administration
Title
Blood Pressure at 60 Minutes
Time Frame
60 minutes after drug administration
Title
Heart Rate at 60 Minutes
Time Frame
60 minutes after drug administration
Title
Respiratory Rate at 60 Minutes
Time Frame
60 minutes after drug administration
Title
Pulse Oximetry at 60 Minutes
Description
Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.
Time Frame
60 minutes after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark C Otley, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larisa Ravitskiy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21238825
Citation
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.
Results Reference
result
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
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