Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery

This study has been completed.

Study NCT00578214 Information provided by Mayo Clinic

First Received on December 20, 2007. Last Updated on February 8, 2012 History of Changes

Results First Received: January 13, 2012

Study Type:	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
Conditions:	Basal Cell Carcinoma Squamous Cell Carcinoma Skin Cancer Anxiety
Interventions:	Drug: Randomized Midazolam Other: Placebo Drug: Local Anesthesia Drug: Prospective Midazolam

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients undergoing outpatient Mohs surgery at the Mayo Clinic in Rochester, MN were included in either the randomized arms (midazolam vs placebo) or in the prospective midazolam arm. The study was performed between March 2007 and June 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Randomized Midazolam	Randomized patients receiving single-dose midazolam syrup
Placebo	Randomized patients receiving placebo syrup
Prospective Midazolam	Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible

Participant Flow: Overall Study

	Randomized Midazolam	Placebo	Prospective Midazolam
STARTED	22	22	31
COMPLETED	22	22	31
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Randomized Midazolam	Randomized patients receiving single-dose midazolam syrup
Placebo	Randomized patients receiving placebo syrup
Prospective Midazolam	Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible

Baseline Measures

	Randomized Midazolam	Placebo	Prospective Midazolam	Total
Number of Participants [units: participants]	22	22	31	75
Age [units: years] Mean ± Standard Deviation	71.9 ± 11.5	70.1 ± 12.8	62.9 ± 14.1	67.7 ± 13.4
Gender [units: participants]
Female	9	10	21	40
Male	13	12	10	35
Region of Enrollment [units: participants]
United States	22	22	31	75
Weight at study entry [units: kg] Mean ± Standard Deviation	83.1 ± 13.23	80.6 ± 11.82	87.8 ± 20.16	84.3 ± 16.2
Prior Mohs Micrographic Surgery [units: participants]
No	16	17	21	54
Yes	5	4	9	18
Unknown	1	1	1	3
Type of Non-melanoma Skin Cancer [units: participants]
Basal Cell Carcinoma	13	11	22	46
Squamous Cell Carcinoma	9	10	8	27
Basal Cell and Squamous Cell Carcinomas	0	1	1	2

Outcome Measures

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1. Primary:

Patient Anxiety at Baseline [ Time Frame: Baseline (prior to drug administration) ]

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2. Primary:

Patient Anxiety at 60 and 120 Minutes [ Time Frame: 60 and 120 minutes after drug administration ]

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3. Secondary:

Patient Alertness at Baseline [ Time Frame: Baseline (prior to drug administration) ]

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4. Secondary:

Patient Alertness at 60 and 120 Minutes [ Time Frame: 60 and 120 minutes after drug administration ]

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5. Secondary:

Patient Cognitive Function at Baseline and 60 Minutes [ Time Frame: baseline (prior to drug administration) and 60 minutes after drug administration ]

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6. Secondary:

Patient Cognitive Function at 120 Minutes [ Time Frame: 120 minutes after drug administration ]

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7. Secondary:

Blood Pressure at 30 Minutes [ Time Frame: 30 minutes after drug administration ]

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8. Secondary:

Heart Rate at 30 Minutes [ Time Frame: 30 minutes after drug administration ]

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9. Secondary:

Respiratory Rate at 30 Minutes [ Time Frame: 30 minutes after drug administration ]

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10. Secondary:

Pulse Oximetry at 30 Minutes [ Time Frame: 30 minutes after drug administration ]

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11. Secondary:

Blood Pressure at 60 Minutes [ Time Frame: 60 minutes after drug administration ]

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12. Secondary:

Heart Rate at 60 Minutes [ Time Frame: 60 minutes after drug administration ]

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13. Secondary:

Respiratory Rate at 60 Minutes [ Time Frame: 60 minutes after drug administration ]

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14. Secondary:

Pulse Oximetry at 60 Minutes [ Time Frame: 60 minutes after drug administration ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was hindered by slow accrual and fell short of reaching the target number of patients.

Results Point of Contact:

Name/Title: Dr. Clark C. Otley
Organization: Mayo Clinic
phone: 507-284-3579
e-mail: otley.clark@mayo.edu

Publications of Results:

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.

Responsible Party:	Larisa Ravitskiy, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00578214 History of Changes
Other Study ID Numbers:	07-000848
Study First Received:	December 20, 2007
Results First Received:	January 13, 2012
Last Updated:	February 8, 2012
Health Authority:	United States: Institutional Review Board