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Patient Satisfaction With Propofol for Out Patient Colonoscopy

Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02937506
Enrollment
600
Registered
2016-10-18
Start date
2013-11-30
Completion date
2016-08-31
Last updated
2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, IBS, Polyps

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

DRUGPropofol

The intervention is to use propofol as anesthesia during a colonoscopy.

DRUGFentanyl Plus Midazolam

The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.

Sponsors

Mount Carmel Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Patient SatisfactionPatient satisfaction was assessed the day of the procedure.Satisfaction assessed using self-developed questionnaire.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total600

Baseline characteristics

CharacteristicPropofolFentanyl Plus Midazolam OnlyTotal
Age, Continuous61.4 Years
STANDARD_DEVIATION 9.8
61.0 Years
STANDARD_DEVIATION 9.4
61.2 Years
STANDARD_DEVIATION 9.6
Sex: Female, Male
Female
138 Participants147 Participants285 Participants
Sex: Female, Male
Male
162 Participants153 Participants315 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3000 / 300
other
Total, other adverse events
7 / 30017 / 300
serious
Total, serious adverse events
0 / 3000 / 300

Outcome results

Primary

Patient Satisfaction

Satisfaction assessed using self-developed questionnaire.

Time frame: Patient satisfaction was assessed the day of the procedure.

Population: Same as enrolled.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
PropofolPatient SatisfactionSatisfied37 Participants
PropofolPatient SatisfactionNeutral/Less than satisfied4 Participants
PropofolPatient SatisfactionVery Satisfied259 Participants
Fentanyl Plus Midazolam OnlyPatient SatisfactionVery Satisfied222 Participants
Fentanyl Plus Midazolam OnlyPatient SatisfactionSatisfied66 Participants
Fentanyl Plus Midazolam OnlyPatient SatisfactionNeutral/Less than satisfied12 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026