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Propofol vs Propofol + Benzo/Opiates in High Risk Group

NCT01315158 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-10-28

Study results available
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Summary

This will be a randomized controlled trial that compares the rates of sedation related complications in high risk patients (ASA greater or equal to 3, BMI greater or equal to 30, those at risk for OSA) undergoing advanced endoscopy procedures with propofol alone compared to propofol in combination with benzodiazepines and opioids.

Conditions

Interventions

DRUG

Propofol Alone

Recommended Propofol doses before considering crossover: * Induction: 2-2.5 mg/kg * Maintenance: 0.1-0.2 mg/kg/min

DRUG

Propofol+Benzo/Opioids

1. Recommended Versed: a. Prior to intubation * patient is \< 50 kg = 1 mg Versed * patient is 50-75 kg = 1.5 mg Versed * patient is \> 75 kg = 2 mg Versed 2. Recommended Fentanyl 1. Prior to intubation = 0.5 ug/kg 2. Total procedural dose = 1 ug/kg

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Faris Murad, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01315158 on ClinicalTrials.gov