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Probability Ramp Control of Propofol for EGD

NCT01838304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-23

Study results available
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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.

Conditions

  • Gastrointestinal Disease

Interventions

DEVICE

Probability ramp control

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

DEVICE

Monitoring

Manual recording of drug doses determined by CRNA

Sponsors & Collaborators

Principal Investigators

  • Jeff E Mandel, MD MS · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01838304 on ClinicalTrials.gov