Colonoscopy, Conscious Sedation, Endoscopy, Digestive System
Conditions
Keywords
Propofol, Diprivan, Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
Brief summary
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.
Interventions
DEVICEComputer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
propofol sedation per device instructions for use
OTHERbenzodiazepines and opioid sedation
per site's current standard of care
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old * Able to comprehend, sign, and date the written informed consent form * English as primary language * Undergoing a non-emergent EGD or colonoscopy * Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure * American Society of Anesthesiologists (ASA) Class I, II or III
Exclusion criteria
* Allergy or inability to tolerate study medications or components of study medications * Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty * Currently using a fentanyl patch * History of diagnosed sleep apnea * History of diagnosed gastroparesis * Baseline oxygen saturation \< 90% (room air) * Pregnant or nursing females * Body mass index (BMI) ≥ 35 * Participation in a clinical trial within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve for Oxygen Desaturation (AUCDesat) | From administration of initial drug dose until subject recovered from effects of sedation | AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds\*percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Deep Sedation/General Anesthesia | From first dose until subject recovered from effects of sedation | Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores. |
| Patient Satisfaction | 24-48 hours post sedation | Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied. |
| Clinician Satisfaction | Post procedure | Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied. |
| Recovery Time (From Sedation) | from scope out until first of two consecutive MOAA/S scores of 5 | Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sedation System Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | 496 |
| Current Standard of Care Site's current standard used for delivery of sedation | 504 |
| Total | 1,000 |
Baseline characteristics
| Characteristic | Sedation System | Current Standard of Care | Total |
|---|---|---|---|
| Age Continuous | 53 years STANDARD_DEVIATION 13 | 53 years STANDARD_DEVIATION 14 | 53 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 496 participants | 504 participants | 1000 participants |
| Sex: Female, Male Female | 266 Participants | 248 Participants | 514 Participants |
| Sex: Female, Male Male | 230 Participants | 256 Participants | 486 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 489 | 27 / 504 |
| serious Total, serious adverse events | 0 / 496 | 1 / 504 |
Outcome results
Primary
Area Under the Curve for Oxygen Desaturation (AUCDesat)
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds\*percent.
Time frame: From administration of initial drug dose until subject recovered from effects of sedation
Population: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sedation System | Area Under the Curve for Oxygen Desaturation (AUCDesat) | 23.6 seconds*percent of oxygen desaturation |
| Current Standard of Care | Area Under the Curve for Oxygen Desaturation (AUCDesat) | 88.0 seconds*percent of oxygen desaturation |
p-value: 0.028ANOVA
Secondary
Clinician Satisfaction
Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.
Time frame: Post procedure
Population: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sedation System | Clinician Satisfaction | 92.2 Scores on a scale |
| Current Standard of Care | Clinician Satisfaction | 76.3 Scores on a scale |
p-value: <0.001ANOVA
Secondary
Duration of Deep Sedation/General Anesthesia
Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.
Time frame: From first dose until subject recovered from effects of sedation
Population: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation System | Duration of Deep Sedation/General Anesthesia | 0.1 minutes | Standard Deviation 1 |
| Current Standard of Care | Duration of Deep Sedation/General Anesthesia | 0.1 minutes | Standard Deviation 1.1 |
Secondary
Patient Satisfaction
Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.
Time frame: 24-48 hours post sedation
Population: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sedation System | Patient Satisfaction | 92.3 Scores on a scale |
| Current Standard of Care | Patient Satisfaction | 89.7 Scores on a scale |
p-value: 0.007ANOVA
Secondary
Recovery Time (From Sedation)
Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.
Time frame: from scope out until first of two consecutive MOAA/S scores of 5
Population: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation System | Recovery Time (From Sedation) | 2.9 minutes | Standard Deviation 2.4 |
| Current Standard of Care | Recovery Time (From Sedation) | 6.5 minutes | Standard Deviation 7 |