Trial · NCT00578214

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

NCT00578214, Not applicable, Completed, Mayo Clinic; results first posted 2012-02-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery. Trials, record NCT00578214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578214

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
NCT number: NCT00578214
Status: Completed
Phases: Not applicable
Enrollment: 75 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer, Anxiety
Interventions: Randomized Midazolam, Placebo, Local Anesthesia, Prospective Midazolam
First posted: 2007-12-21
Last updated: 2012-02-09
Results first posted: 2012-02-09
Limitations and caveats: The study was hindered by slow accrual and fell short of reaching the target number of patients.

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient Anxiety at Baseline	Baseline (prior to drug administration)	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).
Primary	Patient Anxiety at 60 and 120 Minutes	60 and 120 minutes after drug administration	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	Patient Alertness at Baseline	Baseline (prior to drug administration)	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).
Secondary	Patient Alertness at 60 and 120 Minutes	60 and 120 minutes after drug administration	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).
Secondary	Patient Cognitive Function at Baseline and 60 Minutes	baseline (prior to drug administration) and 60 minutes after drug administration	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).
Secondary	Patient Cognitive Function at 120 Minutes	120 minutes after drug administration	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).
Secondary	Blood Pressure at 30 Minutes	30 minutes after drug administration
Secondary	Heart Rate at 30 Minutes	30 minutes after drug administration
Secondary	Respiratory Rate at 30 Minutes	30 minutes after drug administration
Secondary	Pulse Oximetry at 30 Minutes	30 minutes after drug administration	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%.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patient Anxiety at Baseline	Baseline (prior to drug administration)	The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm, 2 patients in the placebo arm, and 1 patient in the prospective midazolam arm did not complete this assessment.	units on a scale	MEAN
SECONDARY	Patient Alertness at Baseline	Baseline (prior to drug administration)	The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.	units on a scale	MEAN
SECONDARY	Patient Alertness at 60 and 120 Minutes	60 and 120 minutes after drug administration	The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm and 1 patient in the prospective midazolam arm did not complete this assessment.	units on a scale	MEAN
PRIMARY	Patient Anxiety at 60 and 120 Minutes	60 and 120 minutes after drug administration	The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.	units on a scale	MEAN
SECONDARY	Patient Cognitive Function at Baseline and 60 Minutes	baseline (prior to drug administration) and 60 minutes after drug administration	The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment.	units on a scale	MEAN
SECONDARY	Patient Cognitive Function at 120 Minutes	120 minutes after drug administration	The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment.	units on a scale	MEAN
SECONDARY	Blood Pressure at 30 Minutes	30 minutes after drug administration		mm Hg	MEAN
SECONDARY	Heart Rate at 30 Minutes	30 minutes after drug administration	The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment.	heart beats per minute	MEAN
SECONDARY	Respiratory Rate at 30 Minutes	30 minutes after drug administration	The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.	breaths per minute	MEAN
SECONDARY	Pulse Oximetry at 30 Minutes	30 minutes after drug administration	The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.	percentage of oxygenation	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group57

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Patient Anxiety at Baseline	Randomized Midazolam		1.3	Standard Deviation 1.5	units on a scale
Patient Anxiety at Baseline	Placebo		1.4	Standard Deviation 1.6	units on a scale
Patient Anxiety at Baseline	Prospective Midazolam		3.4	Standard Deviation 2.7	units on a scale
Patient Alertness at Baseline	Randomized Midazolam		0.2	Standard Deviation 0.6	units on a scale
Patient Alertness at Baseline	Placebo		0.2	Standard Deviation 0.7	units on a scale
Patient Alertness at Baseline	Prospective Midazolam		0.2	Standard Deviation 0.6	units on a scale
Patient Alertness at 60 and 120 Minutes	Randomized Midazolam	60 min patient alertness	3.7	Standard Error 4.0	units on a scale
Patient Alertness at 60 and 120 Minutes	Placebo	60 min patient alertness	0.7	Standard Error 1.6	units on a scale
Patient Alertness at 60 and 120 Minutes	Prospective Midazolam	60 min patient alertness	5.1	Standard Error 3.4	units on a scale
Patient Alertness at 60 and 120 Minutes	Randomized Midazolam	120 min patient alertness	2.1	Standard Error 2.9	units on a scale

1 to 10 of 57Source ClinicalTrials.gov

See all 57 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Randomized Midazolam	22
Overall Study	STARTED	Placebo	22
Overall Study	STARTED	Prospective Midazolam	31
Overall Study	COMPLETED	Randomized Midazolam	22
Overall Study	COMPLETED	Placebo	22
Overall Study	COMPLETED	Prospective Midazolam	31
Overall Study	NOT COMPLETED	Randomized Midazolam	0
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Prospective Midazolam	0

Source ClinicalTrials.gov

Adverse events3

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Mild and transient hypoxia	Respiratory, thoracic and mediastinal disorders	Randomized Midazolam	0	22	0
other	Mild and transient hypoxia	Respiratory, thoracic and mediastinal disorders	Placebo	0	22	0
other	Mild and transient hypoxia	Respiratory, thoracic and mediastinal disorders	Prospective Midazolam	1	31	1

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Randomized Midazolam
Total, all-cause mortality	Placebo
Total, all-cause mortality	Prospective Midazolam
Total, other adverse events	Randomized Midazolam	0	22
Total, other adverse events	Placebo	0	22
Total, other adverse events	Prospective Midazolam	1	31
Total, serious adverse events	Randomized Midazolam	0	22
Total, serious adverse events	Placebo	0	22
Total, serious adverse events	Prospective Midazolam	0	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21238825	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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