Colon CancerNCT01488045
Compare Propofol to Fentanyl and Midazolam for Colonoscopy
A study testing Fentanyl, Propofol and Midazolam in people with Colon Cancer and Rectal Cancer, run by Trinity Health Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- What is being tested?
- Fentanyl, Propofol and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Elective outpatient colonoscopy
- American Society of Anesthesiology Class (ASA) < IV
Who cannot join
- Age < 18
- Inpatient status
- Emergency procedure
- History of colonic or rectal resection
- History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
- ASA of IV
Show all 12Show fewer
- Neurological deficit
- Acute gastrointestinal bleeding
- On anticoagulation agents
- Noncompliance with bowel regiment
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
About this study
Official title: Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
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.
Read the detailed description
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.
- Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
- Difficulty of procedure rated by the physician on a scale of 0-10
- Colonoscopy completion rates (intubation of cecum).
- Complications including oxygen desaturation or hypotension.
- Cost of the two medication regiments
- Conditions
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- Keywords
- Colonoscopy, Propofol, Cancer Screening
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Durogesic, Duragesic, Matrifen
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.
PropofolDrug
Also called Diprivan
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.
MidazolamDrug
Also called Versed
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.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl and Midazolam | Active comparator | Fentanyl and Midazolam sedation for colonoscopy discomfort Receives: Drug: Fentanyl; Drug: Midazolam |
| Propofol | Active comparator | Propofol sedation for colonoscopy discomfort Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (2)
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
Measured: 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")
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: Measured via physician survey within 30 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2015
- Study completionMar 2015
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cleary, MD, Principal investigator, Trinity Health Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488045
- Sponsor's protocol ID
- RCCS 262
- Status last verified
- Apr 2023
- First submitted
- 1 Dec 2011
- Last updated
- 23 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
- ClinicalTrials.gov ID
- NCT01488045
- Acronym / sponsor ID
- RCCS 262
- Conditions
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- Keywords
- Colonoscopy, Propofol, Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Trinity Health MichiganUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Posted 23 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
- Difficulty of procedure rated by the physician on a scale of 0-10
- Colonoscopy completion rates (intubation of cecum).
- Complications including oxygen desaturation or hypotension.
- Cost of the two medication regiments
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl and Midazolam | Active comparator | Drug: Fentanyl, Drug: MidazolamFentanyl and Midazolam sedation for colonoscopy discomfort |
| Propofol | Active comparator | Drug: PropofolPropofol sedation for colonoscopy discomfort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Elective outpatient colonoscopy
- American Society of Anesthesiology Class (ASA) < IV
Key exclusion criteria (12 listed)
- Age < 18
- Inpatient status
- Emergency procedure
- History of colonic or rectal resection
- History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
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 |
|---|---|---|
| FentanylAlso: Durogesic, Duragesic, MatrifenFentanyl 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. | Drug | Fentanyl and Midazolam |
| PropofolAlso: DiprivanPropofol 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. | Drug | Propofol |
| MidazolamAlso: VersedMidazolam 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. | Drug | Fentanyl and Midazolam |
Primary outcome
Patient Satisfaction Scores (Absolute Value)
Time frame: 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")
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).
2 secondary outcomes
Patient Pain & Discomfort Rating (Absolute Value)
Time frame: 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")
Physician Perceptions (Absolute Value)
Time frame: Measured via physician survey within 30 minutes after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- American Society of Colon and Rectal SurgeonsLink provided by the sponsor.
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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.
Robert Cleary, MD principal investigator
Trinity Health Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Propofol and Midazolam in people with Colon Cancer and Rectal Cancer, run by Trinity Health Michigan 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 3 inclusion and 12 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 23 May 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2023). 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 Scores (Absolute Value) (time frame: 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")). 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 23 May 2023.