Anxiety, Basal Cell Carcinoma, Skin Cancer, Squamous Cell Carcinoma
Conditions
Keywords
mohs micrographic surgery, skin cancer, anxiety, basal cell carcinoma, squamous cell carcinoma, midazolam, versed
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.
Interventions
DRUGRandomized Midazolam
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.
OTHERPlacebo
The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
DRUGLocal Anesthesia
Lidocaine 1% with 1:100,000 epinephrine
DRUGProspective Midazolam
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| Blood Pressure at 30 Minutes | 30 minutes after drug administration | — |
| Heart Rate at 30 Minutes | 30 minutes after drug administration | — |
| Respiratory Rate at 30 Minutes | 30 minutes after drug administration | — |
| 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). |
| Blood Pressure at 60 Minutes | 60 minutes after drug administration | — |
| Heart Rate at 60 Minutes | 60 minutes after drug administration | — |
| Respiratory Rate at 60 Minutes | 60 minutes after drug administration | — |
| Pulse Oximetry at 60 Minutes | 60 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%. |
| 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%. |
| 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Randomized Midazolam Randomized patients receiving single-dose midazolam syrup | 22 |
| Placebo Randomized patients receiving placebo syrup | 22 |
| Prospective Midazolam Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible | 31 |
| Total | 75 |
Baseline characteristics
| Characteristic | Total | Placebo | Randomized Midazolam | Prospective Midazolam |
|---|---|---|---|---|
| Age Continuous | 67.7 years STANDARD_DEVIATION 13.4 | 70.1 years STANDARD_DEVIATION 12.8 | 71.9 years STANDARD_DEVIATION 11.5 | 62.9 years STANDARD_DEVIATION 14.1 |
| Prior Mohs Micrographic Surgery No | 54 participants | 17 participants | 16 participants | 21 participants |
| Prior Mohs Micrographic Surgery Unknown | 3 participants | 1 participants | 1 participants | 1 participants |
| Prior Mohs Micrographic Surgery Yes | 18 participants | 4 participants | 5 participants | 9 participants |
| Region of Enrollment United States | 75 participants | 22 participants | 22 participants | 31 participants |
| Sex: Female, Male Female | 40 Participants | 10 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 35 Participants | 12 Participants | 13 Participants | 10 Participants |
| Type of Non-melanoma Skin Cancer Basal Cell and Squamous Cell Carcinomas | 2 participants | 1 participants | 0 participants | 1 participants |
| Type of Non-melanoma Skin Cancer Basal Cell Carcinoma | 46 participants | 11 participants | 13 participants | 22 participants |
| Type of Non-melanoma Skin Cancer Squamous Cell Carcinoma | 27 participants | 10 participants | 9 participants | 8 participants |
| Weight at study entry | 84.3 kg STANDARD_DEVIATION 16.2 | 80.6 kg STANDARD_DEVIATION 11.82 | 83.1 kg STANDARD_DEVIATION 13.23 | 87.8 kg STANDARD_DEVIATION 20.16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 1 / 31 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 31 |
Outcome results
Primary
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).
Time frame: 60 and 120 minutes after drug administration
Population: The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Midazolam | Patient Anxiety at 60 and 120 Minutes | 60 min patient anxiety | 0.1 units on a scale | Standard Deviation 0.5 |
| Randomized Midazolam | Patient Anxiety at 60 and 120 Minutes | 120 min patient anxiety | 0.2 units on a scale | Standard Deviation 0.5 |
| Placebo | Patient Anxiety at 60 and 120 Minutes | 60 min patient anxiety | 0.8 units on a scale | Standard Deviation 0.9 |
| Placebo | Patient Anxiety at 60 and 120 Minutes | 120 min patient anxiety | 0.4 units on a scale | Standard Deviation 0.8 |
| Prospective Midazolam | Patient Anxiety at 60 and 120 Minutes | 120 min patient anxiety | 0.8 units on a scale | Standard Deviation 1.6 |
| Prospective Midazolam | Patient Anxiety at 60 and 120 Minutes | 60 min patient anxiety | 1.0 units on a scale | Standard Deviation 1.7 |
Primary
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).
Time frame: Baseline (prior to drug administration)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Patient Anxiety at Baseline | 1.3 units on a scale | Standard Deviation 1.5 |
| Placebo | Patient Anxiety at Baseline | 1.4 units on a scale | Standard Deviation 1.6 |
| Prospective Midazolam | Patient Anxiety at Baseline | 3.4 units on a scale | Standard Deviation 2.7 |
Secondary
Blood Pressure at 30 Minutes
Time frame: 30 minutes after drug administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Midazolam | Blood Pressure at 30 Minutes | 30 min Systolic Blood Pressure | 121.4 mm Hg | Standard Deviation 19.5 |
| Randomized Midazolam | Blood Pressure at 30 Minutes | 30 min Diastolic Blood Pressure | 67.1 mm Hg | Standard Deviation 12.9 |
| Placebo | Blood Pressure at 30 Minutes | 30 min Systolic Blood Pressure | 125.9 mm Hg | Standard Deviation 12.24 |
| Placebo | Blood Pressure at 30 Minutes | 30 min Diastolic Blood Pressure | 68.4 mm Hg | Standard Deviation 7.82 |
| Prospective Midazolam | Blood Pressure at 30 Minutes | 30 min Systolic Blood Pressure | 118.5 mm Hg | Standard Deviation 16.99 |
| Prospective Midazolam | Blood Pressure at 30 Minutes | 30 min Diastolic Blood Pressure | 63.2 mm Hg | Standard Deviation 10.58 |
Secondary
Blood Pressure at 60 Minutes
Time frame: 60 minutes after drug administration
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Midazolam | Blood Pressure at 60 Minutes | 60 min systolic blood pressure | 120.1 mm Hg | Standard Deviation 18.1 |
| Randomized Midazolam | Blood Pressure at 60 Minutes | 60 min diastolic blood pressure | 65.3 mm Hg | Standard Deviation 9.17 |
| Placebo | Blood Pressure at 60 Minutes | 60 min systolic blood pressure | 131.9 mm Hg | Standard Deviation 14.59 |
| Placebo | Blood Pressure at 60 Minutes | 60 min diastolic blood pressure | 69.5 mm Hg | Standard Deviation 8.69 |
| Prospective Midazolam | Blood Pressure at 60 Minutes | 60 min systolic blood pressure | 113.5 mm Hg | Standard Deviation 15.61 |
| Prospective Midazolam | Blood Pressure at 60 Minutes | 60 min diastolic blood pressure | 61.5 mm Hg | Standard Deviation 10.04 |
Secondary
Heart Rate at 30 Minutes
Time frame: 30 minutes after drug administration
Population: The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Heart Rate at 30 Minutes | 61.7 heart beats per minute | Standard Deviation 14.84 |
| Placebo | Heart Rate at 30 Minutes | 64.3 heart beats per minute | Standard Deviation 8.16 |
| Prospective Midazolam | Heart Rate at 30 Minutes | 72.1 heart beats per minute | Standard Deviation 12.65 |
Secondary
Heart Rate at 60 Minutes
Time frame: 60 minutes after drug administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Heart Rate at 60 Minutes | 60.3 heart beats per minute | Standard Deviation 13.94 |
| Placebo | Heart Rate at 60 Minutes | 61.4 heart beats per minute | Standard Deviation 7.45 |
| Prospective Midazolam | Heart Rate at 60 Minutes | 69.6 heart beats per minute | Standard Deviation 10.75 |
Secondary
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).
Time frame: 60 and 120 minutes after drug administration
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Midazolam | Patient Alertness at 60 and 120 Minutes | 60 min patient alertness | 3.7 units on a scale | Standard Error 4 |
| Randomized Midazolam | Patient Alertness at 60 and 120 Minutes | 120 min patient alertness | 2.1 units on a scale | Standard Error 2.9 |
| Placebo | Patient Alertness at 60 and 120 Minutes | 60 min patient alertness | 0.7 units on a scale | Standard Error 1.6 |
| Placebo | Patient Alertness at 60 and 120 Minutes | 120 min patient alertness | 0.5 units on a scale | Standard Error 1.1 |
| Prospective Midazolam | Patient Alertness at 60 and 120 Minutes | 60 min patient alertness | 5.1 units on a scale | Standard Error 3.4 |
| Prospective Midazolam | Patient Alertness at 60 and 120 Minutes | 120 min patient alertness | 3.4 units on a scale | Standard Error 2.9 |
Secondary
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).
Time frame: Baseline (prior to drug administration)
Population: The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Patient Alertness at Baseline | 0.2 units on a scale | Standard Deviation 0.6 |
| Placebo | Patient Alertness at Baseline | 0.2 units on a scale | Standard Deviation 0.7 |
| Prospective Midazolam | Patient Alertness at Baseline | 0.2 units on a scale | Standard Deviation 0.6 |
Secondary
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).
Time frame: 120 minutes after drug administration
Population: The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Patient Cognitive Function at 120 Minutes | 26.0 units on a scale | Standard Deviation 8.6 |
| Placebo | Patient Cognitive Function at 120 Minutes | 29.2 units on a scale | Standard Deviation 1.2 |
| Prospective Midazolam | Patient Cognitive Function at 120 Minutes | 27.5 units on a scale | Standard Deviation 7 |
Secondary
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).
Time frame: baseline (prior to drug administration) and 60 minutes after drug administration
Population: The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Midazolam | Patient Cognitive Function at Baseline and 60 Minutes | Baseline Cognitive Function | 28.9 units on a scale | Standard Deviation 1.4 |
| Randomized Midazolam | Patient Cognitive Function at Baseline and 60 Minutes | 60 min Cognitive Function | 22.9 units on a scale | Standard Deviation 10.6 |
| Placebo | Patient Cognitive Function at Baseline and 60 Minutes | Baseline Cognitive Function | 29.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Patient Cognitive Function at Baseline and 60 Minutes | 60 min Cognitive Function | 29.4 units on a scale | Standard Deviation 0.7 |
| Prospective Midazolam | Patient Cognitive Function at Baseline and 60 Minutes | Baseline Cognitive Function | 29.2 units on a scale | Standard Deviation 1.9 |
| Prospective Midazolam | Patient Cognitive Function at Baseline and 60 Minutes | 60 min Cognitive Function | 24.3 units on a scale | Standard Deviation 10.9 |
Secondary
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%.
Time frame: 30 minutes after drug administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Pulse Oximetry at 30 Minutes | 94.5 percentage of oxygenation | Standard Deviation 2.18 |
| Placebo | Pulse Oximetry at 30 Minutes | 95.6 percentage of oxygenation | Standard Deviation 2.11 |
| Prospective Midazolam | Pulse Oximetry at 30 Minutes | 95.6 percentage of oxygenation | Standard Deviation 2.56 |
Secondary
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%.
Time frame: 60 minutes after drug administration
Population: The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Pulse Oximetry at 60 Minutes | 94.5 percentage of oxygenation | Standard Deviation 2.43 |
| Placebo | Pulse Oximetry at 60 Minutes | 96.4 percentage of oxygenation | Standard Deviation 1.81 |
| Prospective Midazolam | Pulse Oximetry at 60 Minutes | 95.5 percentage of oxygenation | Standard Deviation 3.03 |
Secondary
Respiratory Rate at 30 Minutes
Time frame: 30 minutes after drug administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Respiratory Rate at 30 Minutes | 19.4 breaths per minute | Standard Deviation 12.26 |
| Placebo | Respiratory Rate at 30 Minutes | 16.1 breaths per minute | Standard Deviation 2.63 |
| Prospective Midazolam | Respiratory Rate at 30 Minutes | 16.2 breaths per minute | Standard Deviation 3.07 |
Secondary
Respiratory Rate at 60 Minutes
Time frame: 60 minutes after drug administration
Population: The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Midazolam | Respiratory Rate at 60 Minutes | 20.6 breaths per minute | Standard Deviation 12.33 |
| Placebo | Respiratory Rate at 60 Minutes | 16.3 breaths per minute | Standard Deviation 2.43 |
| Prospective Midazolam | Respiratory Rate at 60 Minutes | 16.8 breaths per minute | Standard Deviation 2.69 |