Trial · NCT01488045

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

NCT01488045, Not applicable, Completed, Trinity Health Michigan; results first posted 2023-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Compare Propofol to Fentanyl and Midazolam for Colonoscopy. Trials, record NCT01488045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488045

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Compare Propofol to Fentanyl and Midazolam for Colonoscopy
NCT number: NCT01488045
Status: Completed
Phases: Not applicable
Enrollment: 289 participants, actual
Lead sponsor: Trinity Health Michigan
Conditions: Colon Cancer, Rectal Cancer, Colonic Diverticulosis
Interventions: Fentanyl, Propofol, Midazolam
First posted: 2011-12-08
Last updated: 2023-05-23
Results first posted: 2023-05-23
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.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient Satisfaction Scores (Absolute Value)	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).
Secondary	Patient Pain & Discomfort Rating (Absolute Value)	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")	Self-reported by patient via a Visual Analog Scale \[0-10\], where 0=no pain, 10=worst possible pain
Secondary	Physician Perceptions (Absolute Value)	Measured via physician survey within 30 minutes after the procedure	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patient Satisfaction Scores (Absolute Value)	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)	All patients who completed the intervention were included in the analysis	score on a scale	MEAN
SECONDARY	Patient Pain & Discomfort Rating (Absolute Value)	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)	All patients who completed the intervention were included	score on a scale	MEAN
SECONDARY	Physician Perceptions (Absolute Value)	Measured via physician survey within 30 minutes after the procedure		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Patient Satisfaction Scores (Absolute Value)	Propofol Intervention	Recovery Room: Satisfaction with colonoscopy	98.0	Standard Deviation 12.8	score on a scale
Patient Satisfaction Scores (Absolute Value)	Midazolam/Fentanyl Intervention	Recovery Room: Satisfaction with colonoscopy	83.9	Standard Deviation 28.3	score on a scale
Patient Satisfaction Scores (Absolute Value)	Propofol Intervention	Recovery Room: Would undergo another colonoscopy with same sedation	98.1	Standard Deviation 12.6	score on a scale
Patient Satisfaction Scores (Absolute Value)	Midazolam/Fentanyl Intervention	Recovery Room: Would undergo another colonoscopy with same sedation	79.2	Standard Deviation 36.0	score on a scale
Patient Satisfaction Scores (Absolute Value)	Propofol Intervention	Recovery Room: Would encourage others to have same sedation	100.0	Standard Deviation 0	score on a scale
Patient Satisfaction Scores (Absolute Value)	Midazolam/Fentanyl Intervention	Recovery Room: Would encourage others to have same sedation	79.5	Standard Deviation 37.9	score on a scale
Patient Satisfaction Scores (Absolute Value)	Propofol Intervention	Recovery Room: Comfort	88.8	Standard Deviation 25.5	score on a scale
Patient Satisfaction Scores (Absolute Value)	Midazolam/Fentanyl Intervention	Recovery Room: Comfort	86.1	Standard Deviation 25.0	score on a scale
Patient Satisfaction Scores (Absolute Value)	Propofol Intervention	1-5 d postprocedure: Satisfaction with colonoscopy	98.7	Standard Deviation 9.4	score on a scale
Patient Satisfaction Scores (Absolute Value)	Midazolam/Fentanyl Intervention	1-5 d postprocedure: Satisfaction with colonoscopy	79.8	Standard Deviation 34.1	score on a scale

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fentanyl and Midazolam	145
Overall Study	STARTED	Propofol	144
Overall Study	COMPLETED	Fentanyl and Midazolam	136
Overall Study	COMPLETED	Propofol	126
Overall Study	NOT COMPLETED	Fentanyl and Midazolam	9
Overall Study	NOT COMPLETED	Propofol	18

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Decreased oxygen saturation	Surgical and medical procedures	Propofol Intervention	6	126
other	Decreased oxygen saturation	Surgical and medical procedures	Midazolam/Fentanyl Intervention	13	136
other	Decreased heart rate	Surgical and medical procedures	Propofol Intervention	6	126
other	Decreased heart rate	Surgical and medical procedures	Midazolam/Fentanyl Intervention	2	136
other	Decreased blood pressure	Surgical and medical procedures	Propofol Intervention	3	126
other	Decreased blood pressure	Surgical and medical procedures	Midazolam/Fentanyl Intervention	2	136
other	Airway intervention	Surgical and medical procedures	Propofol Intervention	3	126
other	Airway intervention	Surgical and medical procedures	Midazolam/Fentanyl Intervention	2	136
other	Mechanical ventilation	Surgical and medical procedures	Propofol Intervention	0	126
other	Mechanical ventilation	Surgical and medical procedures	Midazolam/Fentanyl Intervention	0	136

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Propofol Intervention	0	126
Total, all-cause mortality	Midazolam/Fentanyl Intervention	0	136
Total, other adverse events	Propofol Intervention	18	126
Total, other adverse events	Midazolam/Fentanyl Intervention	19	136
Total, serious adverse events	Propofol Intervention	0	126
Total, serious adverse events	Midazolam/Fentanyl Intervention	0	136

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Propofol Intervention vs Midazolam/Fentanyl Intervention: deaths from any cause	Trial comparisons
Propofol Intervention vs Midazolam/Fentanyl Intervention: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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