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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl and Midazolam | Active Comparator | Fentanyl and Midazolam sedation for colonoscopy discomfort |
|
| Propofol | Active Comparator | Propofol sedation for colonoscopy discomfort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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") |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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") |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cleary, MD | Trinity Health Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
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| Label | URL |
|---|---|
| American Society of Colon and Rectal Surgeons | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl and Midazolam | Fentanyl and Midazolam sedation for colonoscopy discomfort 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. |
| FG001 | Propofol | Propofol sedation for colonoscopy discomfort Propofol: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol Intervention | Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider. |
| BG001 | Midazolam/Fentanyl Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All patients who completed the intervention were included in the analysis | Posted | Mean | Standard Deviation | score on a scale | 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") |
|
Adverse events were monitored during the procedure and while the patient was in recovery, (the time the patient was in the OR to the time patient had recovered, up to 30 minutes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol Intervention | Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased oxygen saturation | Surgical and medical procedures | Non-systematic Assessment |
This is a single-institution, single endoscopist study and is limited by the inability to perform blinding of the endoscopist.The endoscopist could not be blinded to treatment because of the presence of an anesthesia provider in the colonoscopy suite for the Propofol group. Anesthesia providers were not present for the midazolam/fentanyl group because we wanted to mimic and compare 2 of the most commonly used practice strategies as much as possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert K. Cleary, MD | St. Joseph Mercy Hospital | 734.712.8150 | Robert.Cleary@trinity-health.org |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D043963 | Diverticulosis, Colonic |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
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|
|
| Propofol | Drug | 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. |
|
|
| Midazolam | Drug | 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. |
|
|
| 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. | Measured via physician survey within 30 minutes after the procedure |
| Failure to report exclusion criteria |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI >=30 | Body Mass Index is an index calculated by a person's weight in kilograms divided by the square of height in meters. In this case, the study used a categorical variable of BMI greater than or equal to 30 (yes, no) | Count of Participants | Participants |
|
| General health factors | Comorbidities present at surgery | Count of Participants | Participants |
|
| Procedure/recovery times (min) | Mean | Standard Deviation | minutes |
|
| Amount of anesthetic drug used | The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol). | Mean | Standard Deviation | units |
|
| Cecum intubation | Categorical variable | Count of Participants | Participants |
|
| 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. |
|
|
|
| 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 | All patients who completed the intervention were included | Posted | Mean | Standard Deviation | score on a scale | 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") |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured via physician survey within 30 minutes after the procedure |
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| 18 |
| 126 |
| EG001 | 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. | 0 | 136 | 0 | 136 | 19 | 136 |
| Decreased heart rate | Surgical and medical procedures | Non-systematic Assessment |
|
| Decreased blood pressure | Surgical and medical procedures | Non-systematic Assessment |
|
| Airway intervention | Surgical and medical procedures | Non-systematic Assessment |
|
| Mechanical ventilation | Surgical and medical procedures | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Recovery room: Average discomfort during recovery |
|
| 1-5d postprocedure: Highest pain |
|
| 1-5d postprocedure: Average pain |
|
| 1-5d postprocedure: Average discomfort during recovery |
|
| Endoscopist rating: Difficulty of Procedure |
|
| Endoscopist rating: Bowel preparation |
|
| Endoscopist rating: Patient Movement |
|