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CompletedNCT01488045Updated May 23, 2023Results posted

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

An interventional study of Fentanyl and Propofol in Colon Cancer, Rectal Cancer and Colonic Diverticulosis, sponsored by Saint Joseph Mercy Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Saint Joseph Mercy Health System · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
289
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Colon Cancer
  • Rectal Cancer
  • Colonic Diverticulosis

Keywords

  • Colonoscopy
  • Propofol
  • Cancer Screening
03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's enrollment of 289 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Saint Joseph Mercy Health System is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 18
  • Elective outpatient colonoscopy
  • American Society of Anesthesiology Class (ASA) \< IV

Exclusion criteria

Exclusion Criteria:

  • Age \< 18
  • Inpatient status
  • Emergency procedure
  • History of colonic or rectal resection
  • History of to Propofol (or soy or egg products),Fentanyl or Midazolam
  • ASA of IV
  • Neurological deficit
  • Acute gastrointestinal bleeding
  • On anticoagulation agents
  • Noncompliance with bowel regiment
  • Pregnant women
  • Prisoners
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
289 participants (actual)

Study arms

  • Active comparator
    Fentanyl and Midazolam

    Fentanyl and Midazolam sedation for colonoscopy discomfort

    Drug: Fentanyl · Drug: Midazolam

  • Active comparator
    Propofol

    Propofol sedation for colonoscopy discomfort

    Drug: Propofol

Interventions

  • DrugFentanyl

    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.

    Also known as: Durogesic, Duragesic, Matrifen

  • DrugPropofol

    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.

    Also known as: Diprivan

  • DrugMidazolam

    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.

    Also known as: Versed

06

What researchers measure

Primary outcomes

  1. 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).

    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")

Secondary outcomes

  1. 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

    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")

  2. 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.

    Time frame: Measured via physician survey within 30 minutes after the procedure

07

Results

Posted May 23, 2023
Limitations and caveats
This is a single-institution, single endoscopist study and is limited by the inability to perform blinding of the endoscopist.The endoscopist could not be blinded to treatment because of the presence of an anesthesia provider in the colonoscopy suite for the Propofol group. Anesthesia providers were not present for the midazolam/fentanyl group because we wanted to mimic and compare 2 of the most commonly used practice strategies as much as possible.

Participant flow

Participant flow — Overall Study
MilestoneFentanyl and MidazolamPropofol
Started145144
Completed136126
Not completed918
Withdrew: Withdrawal by subject611
Withdrew: Failure to present for colonoscopy36
Withdrew: Failure to report exclusion criteria01

Outcome measures

PrimaryPatient 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).

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")
Reported as:
Mean · score on a scale
Patient Satisfaction Scores (Absolute Value)
score on a scalePropofol InterventionMidazolam/Fentanyl Intervention
Recovery Room: Satisfaction with colonoscopy98.0 ± 12.883.9 ± 28.3
Recovery Room: Would undergo another colonoscopy with same sedation98.1 ± 12.679.2 ± 36.0
Recovery Room: Would encourage others to have same sedation100.0 ± 079.5 ± 37.9
Recovery Room: Comfort88.8 ± 25.586.1 ± 25.0
1-5 d postprocedure: Satisfaction with colonoscopy98.7 ± 9.479.8 ± 34.1
1-5d postprocedure: Would undergo another colonoscopy with same sedation98.2 ± 12.973.9 ± 41.4
1-5d postprocedure: Would encourage others to have same sedation98.2 ± 13.074.5 ± 41.2
1-5d postprocedure: Comfort94.7 ± 16.584.4 ± 28.9
Statistical analysis
  • Propofol Intervention vs Midazolam/Fentanyl Intervention · Mean difference (final values): -14.0741 · 95% CI -18.5 to -9.6
SecondaryPatient Pain & Discomfort Rating (Absolute Value)

Self-reported by patient via a Visual Analog Scale \[0-10\], where 0=no pain, 10=worst possible pain

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")
Reported as:
Mean · score on a scale
Patient Pain & Discomfort Rating (Absolute Value)
score on a scalePropofol InterventionMidazolam/Fentanyl Intervention
Recovery room: patient highest pain0.2 ± 0.92.4 ± 3.1
Recovery room: Average pain0.8 ± 0.41.9 ± 2.6
Recovery room: Average discomfort during recovery0.7 ± 1.71.2 ± 2.1
1-5d postprocedure: Highest pain0.16 ± 1.01.9 ± 3.2
1-5d postprocedure: Average pain0.4 ± 1.40.7 ± 2.0
1-5d postprocedure: Average discomfort during recovery0.17 ± 1.01.7 ± 3.0
SecondaryPhysician 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.

Time frame:
Measured via physician survey within 30 minutes after the procedure
Reported as:
Mean · score on a scale
Physician Perceptions (Absolute Value)
score on a scalePropofol InterventionMidazolam/Fentanyl Intervention
Endoscopist rating: Highest Pain1.3 ± 1.83.7 ± 2.4
Endoscopist rating: Average Pain0.6 ± 0.82.1 ± 1.8
Endoscopist rating: Difficulty of Procedure4.4 ± 2.75.2 ± 2.5
Endoscopist rating: Bowel preparation1.4 ± 0.61.3 ± 0.6
Endoscopist rating: Patient Movement1.3 ± 2.21.6 ± 1.7

Adverse events

Collected over Adverse events were monitored during the procedure and while the patient was in recovery, (the time the patient was in the OR to the time patient had recovered, up to 30 minutes).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Propofol Intervention0/126 (0%)0/126 (0%)18/126 (14.3%)
Midazolam/Fentanyl Intervention0/136 (0%)0/136 (0%)19/136 (14%)
Most frequent other events
Most frequent other events
EventPropofol InterventionMidazolam/Fentanyl Intervention
Decreased oxygen saturationSurgical and medical procedures6/12613/136
Decreased heart rateSurgical and medical procedures6/1262/136
Decreased blood pressureSurgical and medical procedures3/1262/136
Airway interventionSurgical and medical procedures3/1262/136
Mechanical ventilationSurgical and medical procedures0/1260/136

Baseline characteristics

Age, Continuous
Age, Continuous(years)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Mean57.7 ± 13.458.1 ± 13.857.9 ± 13.6
Sex: Female, Male
Sex: Female, Male(Participants)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Female6160121
Male6576141
BMI >=30
BMI >=30(Participants)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Count of participants384179
General health factors
General health factors(Participants)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Congestive heart failure112
History of myocardial infarction246
Diabetes mellitus81018
Chronic obstructive pulmonary disease257
Obstructive sleep apnea101222
History of diverticulitis5813
IBD123
Ongoing malignancy325
Procedure/recovery times (min)
Procedure/recovery times (min)(minutes)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Procedure time23.0 ± 9.124.4 ± 9.323.73 ± 9.23
Recovery time35.0 ± 7.333.6 ± 15.034.27 ± 11.95
Time in colonoscopy suite34.4 ± 10.338.7 ± 9.736.63 ± 10.22
Amount of anesthetic drug used
Amount of anesthetic drug used(units)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Midazolam, mg—5.7 ± 1.45.7 ± 1.4
Fentanyl, μg—138.8 ± 41.6138.8 ± 41.6
Propofol, mg341.0 ± 122.8—341.0 ± 122.8
Cecum intubation
Cecum intubation(Participants)Propofol InterventionMidazolam/Fentanyl InterventionTotal
Count of participants111116227
08

Study locations

1 site
  • Saint Joseph Mercy Hospital
    Ann Arbor, Michigan 48106, United States
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

Results were first posted in May 2023, 8 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2011
First posted
Dec 8, 2011
Start
Jun 2011
Primary completionActual
Mar 2015
CompletionActual
Mar 2015
Results first posted
May 23, 2023
Last update
May 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01488045
Lead sponsor
Saint Joseph Mercy Health System
Responsible party
Sponsor
First posted
Dec 8, 2011
Start date
Jun 2011
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
May 23, 2023
Last update
May 23, 2023

Study contacts

Robert Cleary, MD
principal investigator · Saint Joseph Mercy Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Fentanyl · Propofol · Midazolam

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