Trial Outcomes & Findings for Patient Satisfaction With Propofol for Out Patient Colonoscopy (NCT NCT02937506)

Results Overview

Satisfaction assessed using self-developed questionnaire.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

600 participants

Primary outcome timeframe

Patient satisfaction was assessed the day of the procedure.

Results posted on

2017-12-26

Participant milestones
Measure	Propofol Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy.	Fentanyl Plus Midazolam Only Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Overall Study STARTED	300	300
Overall Study COMPLETED	300	300
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Patient Satisfaction With Propofol for Out Patient Colonoscopy

Baseline characteristics by cohort
Measure	Propofol n=300 Participants Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy.	Fentanyl Plus Midazolam Only n=300 Participants Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.	Total n=600 Participants Total of all reporting groups
Age, Continuous	61.4 Years STANDARD_DEVIATION 9.8 • n=5 Participants	61.0 Years STANDARD_DEVIATION 9.4 • n=7 Participants	61.2 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	147 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Male	162 Participants n=5 Participants	153 Participants n=7 Participants	315 Participants n=5 Participants

Timeframe: Patient satisfaction was assessed the day of the procedure.

Population: Same as enrolled.

Satisfaction assessed using self-developed questionnaire.

Outcome measures
Measure	Propofol n=300 Participants Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy.	Fentanyl Plus Midazolam Only n=300 Participants Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Patient Satisfaction Very Satisfied	259 Participants	222 Participants
Patient Satisfaction Satisfied	37 Participants	66 Participants
Patient Satisfaction Neutral/Less than satisfied	4 Participants	12 Participants

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Propofol n=300 participants at risk Patients in the treatment arm will be given propofol only when having a colonoscopy. Propofol: The intervention is to use propofol as anesthesia during a colonoscopy.	Fentanyl Plus Midazolam Only n=300 participants at risk Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. Fentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Gastrointestinal disorders Nausea/Emesis	2.3% 7/300 • Number of events 300	5.7% 17/300 • Number of events 300

Mount Carmel Health System

Phone: 614-234-1079