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NCT00578214 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
A NA study of Anxiety and Squamous Cell Carcinoma, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT00578214: Completed NA study of Anxiety and Squamous Cell Carcinoma, sponsored by Mayo Clinic.
NCT00578214 is a NA study of Anxiety and Squamous Cell Carcinoma that has completed, run by Mayo Clinic. The registered enrollment target is 75 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578214, a NA study of Anxiety and Squamous Cell Carcinoma, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Local Anesthesia
- DRUG Randomized Midazolam
- DRUG Prospective Midazolam
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-06 |
| Phase | NA |
What the finished NCT00578214 record still lists
NCT00578214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (83% lower).
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00578214 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00578214 about?
NCT00578214 is a clinical study titled "Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery". 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 ...
What is the current status of trial NCT00578214?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2007-03. Estimated completion is 2008-06.
What conditions does trial NCT00578214 study?
This clinical trial studies the following conditions: Anxiety, Squamous Cell Carcinoma, Skin Cancer, Basal Cell Carcinoma.
What interventions are being tested in trial NCT00578214?
The interventions under investigation include: Placebo (OTHER), Local Anesthesia (DRUG), Randomized Midazolam (DRUG), Prospective Midazolam (DRUG).
Who is sponsoring clinical trial NCT00578214?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00578214 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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75 203rd of 364 higher than 159 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
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