Colon Cancer, IBS, Polyps
Conditions
Keywords
propofol, colonoscopy, patient satisfaction
Brief summary
The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.
Detailed description
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.
Interventions
The intervention is to use propofol as anesthesia during a colonoscopy.
The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Patient satisfaction was assessed the day of the procedure. | Satisfaction assessed using self-developed questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| 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. | 300 |
| Total | 600 |
Baseline characteristics
| Characteristic | Propofol | Fentanyl Plus Midazolam Only | Total |
|---|---|---|---|
| Age, Continuous | 61.4 Years STANDARD_DEVIATION 9.8 | 61.0 Years STANDARD_DEVIATION 9.4 | 61.2 Years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 138 Participants | 147 Participants | 285 Participants |
| Sex: Female, Male Male | 162 Participants | 153 Participants | 315 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 300 |
| other Total, other adverse events | 7 / 300 | 17 / 300 |
| serious Total, serious adverse events | 0 / 300 | 0 / 300 |
Outcome results
Patient Satisfaction
Satisfaction assessed using self-developed questionnaire.
Time frame: Patient satisfaction was assessed the day of the procedure.
Population: Same as enrolled.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Propofol | Patient Satisfaction | Satisfied | 37 Participants |
| Propofol | Patient Satisfaction | Neutral/Less than satisfied | 4 Participants |
| Propofol | Patient Satisfaction | Very Satisfied | 259 Participants |
| Fentanyl Plus Midazolam Only | Patient Satisfaction | Very Satisfied | 222 Participants |
| Fentanyl Plus Midazolam Only | Patient Satisfaction | Satisfied | 66 Participants |
| Fentanyl Plus Midazolam Only | Patient Satisfaction | Neutral/Less than satisfied | 12 Participants |