NCT01838304

Brief Summary

Endoscopic sedation requires titration of propofol to deep sedation without minimum overshoot into general anesthesia. This skill is demanding and acquired slowly. Probability Ramp Control (PRC) simplifies this by providing the clinician with a simple infusion sequence that permits gradual titration of propofol. The purpose of this study is to compare the performance of this technology to that of experienced anesthesia providers in endoscopic sedation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

April 12, 2013

Results QC Date

May 3, 2017

Last Update Submit

January 19, 2018

Conditions

Gastrointestinal Disease

Keywords

propofol sedation endoscopy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Requiring Adjustment in Propofol Dosing

    Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.

    Intraprocedure (average of 9 minutes)

Secondary Outcomes (3)

  • Decrease in Minute Ventilation From Baseline

    Duration of sedation (average of 25 minutes)

  • Time Spent Below a Saturation of 80%

    Duration of sedation (mean 25 minutes)

  • Procedure Time

    Procedure time (average of 9 minutes)

Study Arms (2)

Monitoring

ACTIVE COMPARATOR

Standard of care sedation by CRNA using proposal with manual recording of drug dosing

Device: Monitoring

Probability ramp control

EXPERIMENTAL

Propofol titrated to deep sedation using PRC software.

Device: Probability ramp control

Interventions

Probability ramp controlDEVICE

Decision support software that calculates propofol doses appropriate for age and weight of the patient

Probability ramp control
MonitoringDEVICE

Manual recording of drug doses determined by CRNA

Also known as: Manual recording of drug doses determined by CRNA
Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for elective EGD

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Mandel JE, Sarraf E. The variability of response to propofol is reduced when a clinical observation is incorporated in the control: a simulation study. Anesth Analg. 2012 Jun;114(6):1221-9. doi: 10.1213/ANE.0b013e31824cb853. Epub 2012 Mar 30.

    PMID: 22467886BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Limitations and Caveats

Choice of processed EEG scores in power analyasis; variability of PSI scores; lack of concealed allocation, as it was deemed unethical to ask the CRNAs to deliver "sham propofol" in the experimental arm.

Results Point of Contact

Title
Vice-Chair of Research
Organization
University of Pennsylvania
roderic.eckenhoff@uphs.upenn.edu
(215) 662-3766

Study Officials

  • Jeff E Mandel, MD MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 24, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 23, 2018

Results First Posted

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)