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Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients

NCT01173263 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2014-03-05

No results posted yet for this study

Summary

Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.

Conditions

  • Respiration, Artificial

Interventions

OTHER

BIS 70 maintained

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.

OTHER

BIS level 50

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.

OTHER

BIS 35

Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Alparslan Turan, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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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 NCT01173263 on ClinicalTrials.gov