Colon CancerPhase 4NCT02937506
Patient Satisfaction With Propofol for Out Patient Colonoscopy
A Phase 4 study testing Propofol and Fentanyl Plus Midazolam in people with Colon Cancer and IBS, run by Mount Carmel Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, IBS, Polyps
- What is being tested?
- Propofol and Fentanyl Plus Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having an outpatient colonoscopy
Who cannot join
- High risk patients (ASA IV \& V) who are not candidates for colonoscopy in an outpatient center will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study
The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.
Read the 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.
- Conditions
- Colon Cancer, IBS, Polyps
- Being tested
- Propofol, Fentanyl Plus Midazolam
- Keywords
- propofol, colonoscopy, patient satisfaction
- Medical subject headings
- Colonic Neoplasms, Polyps, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
The intervention is to use propofol as anesthesia during a colonoscopy.
Fentanyl Plus MidazolamDrug
Also called Sublimaze, Versed
The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Patients in the treatment arm will be given propofol only when having a colonoscopy. Receives: Drug: Propofol |
| 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. Receives: Drug: Fentanyl Plus Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Satisfaction assessed using self-developed questionnaire.
Measured: Patient satisfaction was assessed the day of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2013
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anantha Padmanabhan, MD, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937506
- Sponsor's protocol ID
- 131115-3
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 26 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT02937506
- Acronym / sponsor ID
- 131115-3
- Conditions
- Colon Cancer, IBS, Polyps
- Keywords
- propofol, colonoscopy, patient satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 27 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolPatients in the treatment arm will be given propofol only when having a colonoscopy. |
| Fentanyl Plus Midazolam Only | Experimental | Drug: Fentanyl Plus MidazolamPatients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having an outpatient colonoscopy
Key exclusion criteria (1 listed)
- High risk patients (ASA IV \& V) who are not candidates for colonoscopy in an outpatient center will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: DiprivanThe intervention is to use propofol as anesthesia during a colonoscopy. | Drug | Propofol |
| Fentanyl Plus MidazolamAlso: Sublimaze, VersedThe control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy. | Drug | Fentanyl Plus Midazolam Only |
Primary outcome
Patient Satisfaction
Time frame: Patient satisfaction was assessed the day of the procedure.
Satisfaction assessed using self-developed questionnaire.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anantha Padmanabhan, MD principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Fentanyl Plus Midazolam in people with Colon Cancer and IBS, run by Mount Carmel Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Patient satisfaction was assessed the day of the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.