Colon Cancer, Colonic Diverticulosis, Rectal Cancer
Conditions
Keywords
Colonoscopy, Propofol, Cancer Screening
Brief summary
The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.
Detailed description
Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects. Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure. Other Variables of Interest. * Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge. * Difficulty of procedure rated by the physician on a scale of 0-10 * Colonoscopy completion rates (intubation of cecum). * Complications including oxygen desaturation or hypotension. * Cost of the two medication regiments
Interventions
DRUGFentanyl
Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.
DRUGPropofol
Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.
DRUGMidazolam
Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.
Sponsors
Trinity Health Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Elective outpatient colonoscopy * American Society of Anesthesiology Class (ASA) \< IV
Exclusion criteria
* Age \< 18 * Inpatient status * Emergency procedure * History of colonic or rectal resection * History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam * ASA of IV * Neurological deficit * Acute gastrointestinal bleeding * On anticoagulation agents * Noncompliance with bowel regiment * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Scores (Absolute Value) | Survey administered in the recovery room up to 30 minutes following procedure (Recovery room), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure (1-5 d postprocedure) | Measured by the patient using a 100-point Visual Analog Scale (VAS) \[0-100%\] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain & Discomfort Rating (Absolute Value) | Survey administered in the recovery room up to 30 minutes following procedure (Recovery room), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure (1-5 d postprocedure) | Self-reported by patient via a Visual Analog Scale \[0-10\], where 0=no pain, 10=worst possible pain |
| Physician Perceptions (Absolute Value) | Measured via physician survey within 30 minutes after the procedure | Self-reported Physician/Endoscopist perceptions Measured via Visual Analog Scale \[0-10\] of: Highest pain, Average pain, Difficulty of procedure, Bowel preparation, Patient movement. A score of 0 on the scale=no pain/difficulty, while a score of 10=worst possible pain/difficulty/severity. The higher the score the worse the outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propofol Intervention Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider. | 126 |
| Midazolam/Fentanyl Intervention Fentanyl: Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.
Midazolam: Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments. | 136 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to present for colonoscopy | 3 | 6 |
| Overall Study | Failure to report exclusion criteria | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 11 |
Baseline characteristics
| Characteristic | Propofol Intervention | Total | Midazolam/Fentanyl Intervention |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 13.4 | 57.9 years STANDARD_DEVIATION 13.6 | 58.1 years STANDARD_DEVIATION 13.8 |
| Amount of anesthetic drug used Fentanyl, μg | — | 138.8 units STANDARD_DEVIATION 41.6 | 138.8 units STANDARD_DEVIATION 41.6 |
| Amount of anesthetic drug used Midazolam, mg | — | 5.7 units STANDARD_DEVIATION 1.4 | 5.7 units STANDARD_DEVIATION 1.4 |
| Amount of anesthetic drug used Propofol, mg | 341.0 units STANDARD_DEVIATION 122.8 | 341.0 units STANDARD_DEVIATION 122.8 | — |
| BMI >=30 | 38 Participants | 79 Participants | 41 Participants |
| Cecum intubation | 111 Participants | 227 Participants | 116 Participants |
| General health factors Chronic obstructive pulmonary disease | 2 Participants | 7 Participants | 5 Participants |
| General health factors Congestive heart failure | 1 Participants | 2 Participants | 1 Participants |
| General health factors Diabetes mellitus | 8 Participants | 18 Participants | 10 Participants |
| General health factors History of diverticulitis | 5 Participants | 13 Participants | 8 Participants |
| General health factors History of myocardial infarction | 2 Participants | 6 Participants | 4 Participants |
| General health factors IBD | 1 Participants | 3 Participants | 2 Participants |
| General health factors Obstructive sleep apnea | 10 Participants | 22 Participants | 12 Participants |
| General health factors Ongoing malignancy | 3 Participants | 5 Participants | 2 Participants |
| Procedure/recovery times (min) Procedure time | 23.0 minutes STANDARD_DEVIATION 9.1 | 23.73 minutes STANDARD_DEVIATION 9.23 | 24.4 minutes STANDARD_DEVIATION 9.3 |
| Procedure/recovery times (min) Recovery time | 35.0 minutes STANDARD_DEVIATION 7.3 | 34.27 minutes STANDARD_DEVIATION 11.95 | 33.6 minutes STANDARD_DEVIATION 15 |
| Procedure/recovery times (min) Time in colonoscopy suite | 34.4 minutes STANDARD_DEVIATION 10.3 | 36.63 minutes STANDARD_DEVIATION 10.22 | 38.7 minutes STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 61 Participants | 121 Participants | 60 Participants |
| Sex: Female, Male Male | 65 Participants | 141 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 136 |
| other Total, other adverse events | 18 / 126 | 19 / 136 |
| serious Total, serious adverse events | 0 / 126 | 0 / 136 |
Outcome results
Primary
Patient Satisfaction Scores (Absolute Value)
Measured by the patient using a 100-point Visual Analog Scale (VAS) \[0-100%\] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome).
Time frame: Survey administered in the recovery room up to 30 minutes following procedure (Recovery room), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure (1-5 d postprocedure)
Population: All patients who completed the intervention were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Satisfaction with colonoscopy | 98.0 score on a scale | Standard Deviation 12.8 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Would undergo another colonoscopy with same sedation | 98.1 score on a scale | Standard Deviation 12.6 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Would encourage others to have same sedation | 100.0 score on a scale | Standard Deviation 0 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Comfort | 88.8 score on a scale | Standard Deviation 25.5 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5 d postprocedure: Satisfaction with colonoscopy | 98.7 score on a scale | Standard Deviation 9.4 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5d postprocedure: Would undergo another colonoscopy with same sedation | 98.2 score on a scale | Standard Deviation 12.9 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5d postprocedure: Would encourage others to have same sedation | 98.2 score on a scale | Standard Deviation 13 |
| Propofol Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5d postprocedure: Comfort | 94.7 score on a scale | Standard Deviation 16.5 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5d postprocedure: Comfort | 84.4 score on a scale | Standard Deviation 28.9 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Satisfaction with colonoscopy | 83.9 score on a scale | Standard Deviation 28.3 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5 d postprocedure: Satisfaction with colonoscopy | 79.8 score on a scale | Standard Deviation 34.1 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Would undergo another colonoscopy with same sedation | 79.2 score on a scale | Standard Deviation 36 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5d postprocedure: Would encourage others to have same sedation | 74.5 score on a scale | Standard Deviation 41.2 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Would encourage others to have same sedation | 79.5 score on a scale | Standard Deviation 37.9 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | 1-5d postprocedure: Would undergo another colonoscopy with same sedation | 73.9 score on a scale | Standard Deviation 41.4 |
| Midazolam/Fentanyl Intervention | Patient Satisfaction Scores (Absolute Value) | Recovery Room: Comfort | 86.1 score on a scale | Standard Deviation 25 |
Comparison: To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.95% CI: [-18.5, -9.6]
Secondary
Patient Pain & Discomfort Rating (Absolute Value)
Self-reported by patient via a Visual Analog Scale \[0-10\], where 0=no pain, 10=worst possible pain
Time frame: Survey administered in the recovery room up to 30 minutes following procedure (Recovery room), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure (1-5 d postprocedure)
Population: All patients who completed the intervention were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol Intervention | Patient Pain & Discomfort Rating (Absolute Value) | Recovery room: patient highest pain | 0.2 score on a scale | Standard Deviation 0.9 |
| Propofol Intervention | Patient Pain & Discomfort Rating (Absolute Value) | Recovery room: Average pain | 0.8 score on a scale | Standard Deviation 0.4 |
| Propofol Intervention | Patient Pain & Discomfort Rating (Absolute Value) | Recovery room: Average discomfort during recovery | 0.7 score on a scale | Standard Deviation 1.7 |
| Propofol Intervention | Patient Pain & Discomfort Rating (Absolute Value) | 1-5d postprocedure: Highest pain | 0.16 score on a scale | Standard Deviation 1 |
| Propofol Intervention | Patient Pain & Discomfort Rating (Absolute Value) | 1-5d postprocedure: Average pain | 0.4 score on a scale | Standard Deviation 1.4 |
| Propofol Intervention | Patient Pain & Discomfort Rating (Absolute Value) | 1-5d postprocedure: Average discomfort during recovery | 0.17 score on a scale | Standard Deviation 1 |
| Midazolam/Fentanyl Intervention | Patient Pain & Discomfort Rating (Absolute Value) | 1-5d postprocedure: Average pain | 0.7 score on a scale | Standard Deviation 2 |
| Midazolam/Fentanyl Intervention | Patient Pain & Discomfort Rating (Absolute Value) | Recovery room: patient highest pain | 2.4 score on a scale | Standard Deviation 3.1 |
| Midazolam/Fentanyl Intervention | Patient Pain & Discomfort Rating (Absolute Value) | 1-5d postprocedure: Highest pain | 1.9 score on a scale | Standard Deviation 3.2 |
| Midazolam/Fentanyl Intervention | Patient Pain & Discomfort Rating (Absolute Value) | Recovery room: Average pain | 1.9 score on a scale | Standard Deviation 2.6 |
| Midazolam/Fentanyl Intervention | Patient Pain & Discomfort Rating (Absolute Value) | 1-5d postprocedure: Average discomfort during recovery | 1.7 score on a scale | Standard Deviation 3 |
| Midazolam/Fentanyl Intervention | Patient Pain & Discomfort Rating (Absolute Value) | Recovery room: Average discomfort during recovery | 1.2 score on a scale | Standard Deviation 2.1 |
Secondary
Physician Perceptions (Absolute Value)
Self-reported Physician/Endoscopist perceptions Measured via Visual Analog Scale \[0-10\] of: Highest pain, Average pain, Difficulty of procedure, Bowel preparation, Patient movement. A score of 0 on the scale=no pain/difficulty, while a score of 10=worst possible pain/difficulty/severity. The higher the score the worse the outcome.
Time frame: Measured via physician survey within 30 minutes after the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Average Pain | 0.6 score on a scale | Standard Deviation 0.8 |
| Propofol Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Bowel preparation | 1.4 score on a scale | Standard Deviation 0.6 |
| Propofol Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Difficulty of Procedure | 4.4 score on a scale | Standard Deviation 2.7 |
| Propofol Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Patient Movement | 1.3 score on a scale | Standard Deviation 2.2 |
| Propofol Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Highest Pain | 1.3 score on a scale | Standard Deviation 1.8 |
| Midazolam/Fentanyl Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Patient Movement | 1.6 score on a scale | Standard Deviation 1.7 |
| Midazolam/Fentanyl Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Highest Pain | 3.7 score on a scale | Standard Deviation 2.4 |
| Midazolam/Fentanyl Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Average Pain | 2.1 score on a scale | Standard Deviation 1.8 |
| Midazolam/Fentanyl Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Difficulty of Procedure | 5.2 score on a scale | Standard Deviation 2.5 |
| Midazolam/Fentanyl Intervention | Physician Perceptions (Absolute Value) | Endoscopist rating: Bowel preparation | 1.3 score on a scale | Standard Deviation 0.6 |