Trial Outcomes & Findings for Compare Propofol to Fentanyl and Midazolam for Colonoscopy (NCT NCT01488045)

Last Updated: 2023-05-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

289 participants

Primary outcome timeframe

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")

Results posted on

2023-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Fentanyl and Midazolam Fentanyl and Midazolam sedation for colonoscopy discomfort Fentanyl: 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. Midazolam: 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.	Propofol Propofol sedation for colonoscopy discomfort Propofol: 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.
Overall Study STARTED	145	144
Overall Study COMPLETED	136	126
Overall Study NOT COMPLETED	9	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Fentanyl and Midazolam Fentanyl and Midazolam sedation for colonoscopy discomfort Fentanyl: 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. Midazolam: 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.	Propofol Propofol sedation for colonoscopy discomfort Propofol: 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.
Overall Study Withdrawal by Subject	6	11
Overall Study Failure to present for colonoscopy	3	6
Overall Study Failure to report exclusion criteria	0	1

Baseline Characteristics

The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol Intervention n=126 Participants Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider.	Midazolam/Fentanyl Intervention n=136 Participants Fentanyl: 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. Midazolam: 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.	Total n=262 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 13.4 • n=126 Participants	58.1 years STANDARD_DEVIATION 13.8 • n=136 Participants	57.9 years STANDARD_DEVIATION 13.6 • n=262 Participants
Sex: Female, Male Female	61 Participants n=126 Participants	60 Participants n=136 Participants	121 Participants n=262 Participants
Sex: Female, Male Male	65 Participants n=126 Participants	76 Participants n=136 Participants	141 Participants n=262 Participants
BMI >=30	38 Participants n=126 Participants	41 Participants n=136 Participants	79 Participants n=262 Participants
General health factors Congestive heart failure	1 Participants n=126 Participants	1 Participants n=136 Participants	2 Participants n=262 Participants
General health factors History of myocardial infarction	2 Participants n=126 Participants	4 Participants n=136 Participants	6 Participants n=262 Participants
General health factors Diabetes mellitus	8 Participants n=126 Participants	10 Participants n=136 Participants	18 Participants n=262 Participants
General health factors Chronic obstructive pulmonary disease	2 Participants n=126 Participants	5 Participants n=136 Participants	7 Participants n=262 Participants
General health factors Obstructive sleep apnea	10 Participants n=126 Participants	12 Participants n=136 Participants	22 Participants n=262 Participants
General health factors History of diverticulitis	5 Participants n=126 Participants	8 Participants n=136 Participants	13 Participants n=262 Participants
General health factors IBD	1 Participants n=126 Participants	2 Participants n=136 Participants	3 Participants n=262 Participants
General health factors Ongoing malignancy	3 Participants n=126 Participants	2 Participants n=136 Participants	5 Participants n=262 Participants
Procedure/recovery times (min) Procedure time	23.0 minutes STANDARD_DEVIATION 9.1 • n=126 Participants	24.4 minutes STANDARD_DEVIATION 9.3 • n=136 Participants	23.73 minutes STANDARD_DEVIATION 9.23 • n=262 Participants
Procedure/recovery times (min) Recovery time	35.0 minutes STANDARD_DEVIATION 7.3 • n=126 Participants	33.6 minutes STANDARD_DEVIATION 15.0 • n=136 Participants	34.27 minutes STANDARD_DEVIATION 11.95 • n=262 Participants
Procedure/recovery times (min) Time in colonoscopy suite	34.4 minutes STANDARD_DEVIATION 10.3 • n=126 Participants	38.7 minutes STANDARD_DEVIATION 9.7 • n=136 Participants	36.63 minutes STANDARD_DEVIATION 10.22 • n=262 Participants
Amount of anesthetic drug used Midazolam, mg	—	5.7 units STANDARD_DEVIATION 1.4 • n=136 Participants • The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).	5.7 units STANDARD_DEVIATION 1.4 • n=136 Participants • The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).
Amount of anesthetic drug used Fentanyl, μg	—	138.8 units STANDARD_DEVIATION 41.6 • n=136 Participants • The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).	138.8 units STANDARD_DEVIATION 41.6 • n=136 Participants • The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).
Amount of anesthetic drug used Propofol, mg	341.0 units STANDARD_DEVIATION 122.8 • n=126 Participants • The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).	—	341.0 units STANDARD_DEVIATION 122.8 • n=126 Participants • The Row population represents the patients who received that drug which is specific to each Intervention Arm. The Propofol patient group would only receive Propofol (no Midazolam/Fentanyl received), and the M/F group would only receive Midazolam and Fentanyl (no propofol).
Cecum intubation	111 Participants n=126 Participants	116 Participants n=136 Participants	227 Participants n=262 Participants

PRIMARY outcome

Timeframe: 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")

Population: All patients who completed the intervention were included in the analysis

Outcome measures

Outcome measures
Measure	Propofol Intervention n=126 Participants Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider.	Midazolam/Fentanyl Intervention n=136 Participants Fentanyl: 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. Midazolam: 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.
Patient Satisfaction Scores (Absolute Value) Recovery Room: Satisfaction with colonoscopy	98.0 score on a scale Standard Deviation 12.8	83.9 score on a scale Standard Deviation 28.3
Patient Satisfaction Scores (Absolute Value) 1-5d postprocedure: Would encourage others to have same sedation	98.2 score on a scale Standard Deviation 13.0	74.5 score on a scale Standard Deviation 41.2
Patient Satisfaction Scores (Absolute Value) 1-5d postprocedure: Comfort	94.7 score on a scale Standard Deviation 16.5	84.4 score on a scale Standard Deviation 28.9
Patient Satisfaction Scores (Absolute Value) Recovery Room: Would undergo another colonoscopy with same sedation	98.1 score on a scale Standard Deviation 12.6	79.2 score on a scale Standard Deviation 36.0
Patient Satisfaction Scores (Absolute Value) Recovery Room: Would encourage others to have same sedation	100.0 score on a scale Standard Deviation 0	79.5 score on a scale Standard Deviation 37.9
Patient Satisfaction Scores (Absolute Value) Recovery Room: Comfort	88.8 score on a scale Standard Deviation 25.5	86.1 score on a scale Standard Deviation 25.0
Patient Satisfaction Scores (Absolute Value) 1-5 d postprocedure: Satisfaction with colonoscopy	98.7 score on a scale Standard Deviation 9.4	79.8 score on a scale Standard Deviation 34.1
Patient Satisfaction Scores (Absolute Value) 1-5d postprocedure: Would undergo another colonoscopy with same sedation	98.2 score on a scale Standard Deviation 12.9	73.9 score on a scale Standard Deviation 41.4

SECONDARY outcome

Population: All patients who completed the intervention were included

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

Outcome measures

Outcome measures
Measure	Propofol Intervention n=126 Participants Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider.	Midazolam/Fentanyl Intervention n=136 Participants Fentanyl: 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. Midazolam: 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.
Patient Pain & Discomfort Rating (Absolute Value) 1-5d postprocedure: Average pain	0.4 score on a scale Standard Deviation 1.4	0.7 score on a scale Standard Deviation 2.0
Patient Pain & Discomfort Rating (Absolute Value) 1-5d postprocedure: Average discomfort during recovery	0.17 score on a scale Standard Deviation 1.0	1.7 score on a scale Standard Deviation 3.0
Patient Pain & Discomfort Rating (Absolute Value) Recovery room: patient highest pain	0.2 score on a scale Standard Deviation 0.9	2.4 score on a scale Standard Deviation 3.1
Patient Pain & Discomfort Rating (Absolute Value) Recovery room: Average pain	0.8 score on a scale Standard Deviation 0.4	1.9 score on a scale Standard Deviation 2.6
Patient Pain & Discomfort Rating (Absolute Value) Recovery room: Average discomfort during recovery	0.7 score on a scale Standard Deviation 1.7	1.2 score on a scale Standard Deviation 2.1
Patient Pain & Discomfort Rating (Absolute Value) 1-5d postprocedure: Highest pain	0.16 score on a scale Standard Deviation 1.0	1.9 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Propofol Intervention n=126 Participants Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider.	Midazolam/Fentanyl Intervention n=136 Participants Fentanyl: 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. Midazolam: 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.
Physician Perceptions (Absolute Value) Endoscopist rating: Difficulty of Procedure	4.4 score on a scale Standard Deviation 2.7	5.2 score on a scale Standard Deviation 2.5
Physician Perceptions (Absolute Value) Endoscopist rating: Average Pain	0.6 score on a scale Standard Deviation 0.8	2.1 score on a scale Standard Deviation 1.8
Physician Perceptions (Absolute Value) Endoscopist rating: Highest Pain	1.3 score on a scale Standard Deviation 1.8	3.7 score on a scale Standard Deviation 2.4
Physician Perceptions (Absolute Value) Endoscopist rating: Bowel preparation	1.4 score on a scale Standard Deviation 0.6	1.3 score on a scale Standard Deviation 0.6
Physician Perceptions (Absolute Value) Endoscopist rating: Patient Movement	1.3 score on a scale Standard Deviation 2.2	1.6 score on a scale Standard Deviation 1.7

Adverse Events

Propofol Intervention

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Midazolam/Fentanyl Intervention

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Propofol Intervention n=126 participants at risk Propofol: an initial dose of ≤60 mg intravenously, with additional dosing at the discretion of the anesthesia provider.	Midazolam/Fentanyl Intervention n=136 participants at risk Fentanyl: 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. Midazolam: 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.
Surgical and medical procedures Decreased oxygen saturation	4.8% 6/126 • 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).	9.6% 13/136 • 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).
Surgical and medical procedures Decreased heart rate	4.8% 6/126 • 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).	1.5% 2/136 • 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).
Surgical and medical procedures Decreased blood pressure	2.4% 3/126 • 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).	1.5% 2/136 • 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).
Surgical and medical procedures Airway intervention	2.4% 3/126 • 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).	1.5% 2/136 • 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).
Surgical and medical procedures Mechanical ventilation	0.00% 0/126 • 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).	0.00% 0/136 • 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).

Additional Information

Robert K. Cleary, MD

St. Joseph Mercy Hospital

Phone: 734.712.8150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place