Patient Satisfaction With Propofol for Out Patient Colonoscopy

• Sponsor: Mount Carmel Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT02937506
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 18.2

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer; IBS; Polyps	Drug: Propofol; Drug: Fentanyl Plus Midazolam	Phase 4

Detailed Description

Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.

Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol Patients in the treatment arm will be given propofol only when having a colonoscopy.	Drug: Propofol; The intervention is to use propofol as anesthesia during a colonoscopy.; Other Names: Diprivan
Experimental: Fentanyl Plus Midazolam Only Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.	Drug: Fentanyl Plus Midazolam; The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.; Other Names: Sublimaze Versed

Outcome Measures

Primary Outcome Measures

1. Patient Satisfaction [Patient satisfaction was assessed the day of the procedure.]

   Satisfaction assessed using self-developed questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients having an outpatient colonoscopy

Exclusion Criteria:

• High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient center will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Carmel Health System	Columbus	Ohio	United States	43213

Sponsors and Collaborators

• Mount Carmel Health System

Investigators

• Principal Investigator: Anantha Padmanabhan, MD, Mount Carmel Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mount Carmel Health System
• ClinicalTrials.gov Identifier: NCT02937506
• Other Study ID Numbers: 131115-3
• First Posted: Oct 18, 2016
• Last Update Posted: Dec 26, 2017
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mount Carmel Health System: propofol; colonoscopy; patient satisfaction
• Additional relevant MeSH terms: Colonic Neoplasms; Fentanyl; Midazolam; Propofol

Study Results

Participant Flow

Arm/Group Title	Propofol	Fentanyl Plus Midazolam Only
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	300	300
COMPLETED	300	300
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Propofol	Fentanyl Plus Midazolam Only	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	300	300	600
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.4 (9.8)	61.0 (9.4)	61.2 (9.6)
Sex: Female, Male (Count of Participants)
Female	138 46%	147 49%	285 47.5%
Male	162 54%	153 51%	315 52.5%

Outcome Measures

1. Primary Outcome

Title	Patient Satisfaction
Description	Satisfaction assessed using self-developed questionnaire.
Time Frame	Patient satisfaction was assessed the day of the procedure.

Outcome Measure Data

Analysis Population Description

Same as enrolled.

Arm/Group Title	Propofol	Fentanyl Plus Midazolam Only
Arm/Group Description	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.	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.
Measure Participants	300	300
Very Satisfied	259 86.3%	222 74%
Satisfied	37 12.3%	66 22%
Neutral/Less than satisfied	4 1.3%	12 4%

Adverse Events

Arm/Group Title	Propofol		Fentanyl Plus Midazolam Only
Arm/Group Description	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.		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.
All Cause Mortality
	Propofol		Fentanyl Plus Midazolam Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		0/300 (0%)
Serious Adverse Events
	Propofol		Fentanyl Plus Midazolam Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		0/300 (0%)
Other (Not Including Serious) Adverse Events
	Propofol		Fentanyl Plus Midazolam Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/300 (2.3%)		17/300 (5.7%)
Gastrointestinal disorders
Nausea/Emesis	7/300 (2.3%)	300	17/300 (5.7%)	300

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.