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The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.
Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.
Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Experimental | Patients in the treatment arm will be given propofol only when having a colonoscopy. |
|
| Fentanyl Plus Midazolam Only | Experimental | Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | The intervention is to use propofol as anesthesia during a colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Satisfaction assessed using self-developed questionnaire. | Patient satisfaction was assessed the day of the procedure. |
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Inclusion Criteria:
- Patients having an outpatient colonoscopy
Exclusion Criteria:
- High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient center will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Anantha Padmanabhan, MD | Mount Carmel Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Carmel Health System | Columbus | Ohio | 43213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy. |
| FG001 | Fentanyl Plus Midazolam Only | Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients scheduled for an outpatient colonoscopy at a single ambulatory surgery center.
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy. |
| BG001 | Fentanyl Plus Midazolam Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age of the participant in completed years. |
| 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 | Satisfaction assessed using self-developed questionnaire. | Same as enrolled. | Posted | Count of Participants | Participants | Patient satisfaction was assessed the day of the procedure. |
|
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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 | Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Emesis | Gastrointestinal disorders | Systematic Assessment | Nausea or vomiting up to 24 hours after colonoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anantha Padmanabhan, MD | Mount Carmel Health System | 614-234-1079 | apadmanabhan@mchs.com |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D011127 | Polyps |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D005283 | Fentanyl |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Fentanyl Plus Midazolam | Drug | The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy. |
|
|
Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.
Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 300 |
| 0 |
| 300 |
| 7 |
| 300 |
| EG001 | Fentanyl Plus Midazolam Only | Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy. | 0 | 300 | 0 | 300 | 17 | 300 |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |