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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00578214
First received: December 20, 2007
Last updated: February 8, 2012
Last verified: February 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
No text entered.

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
Total Total of all reporting groups

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:


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