Propofol vs Propofol + Benzo/Opiates in High Risk Group

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01315158
First received: March 11, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Obesity
Drug: Propofol Alone
Drug: Propofol+Benzo/Opioids

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incidence of Sedation Related Complications With Propofol Alone Versus Propofol With Benzodiazepines and Opiates in a High Risk Group Undergoing Advanced Endoscopic Procedures: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Frequency of airway maneuvers [ Time Frame: one day (during procedure) ] [ Designated as safety issue: No ]
    In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the frequency of AMs when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.


Secondary Outcome Measures:
  • Frequency of other sedation related complications [ Time Frame: one day (during procedure) ] [ Designated as safety issue: No ]
    We will compare the frequency of other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups

  • Compare propofol doses between the two groups [ Time Frame: one day (during procedure) ] [ Designated as safety issue: No ]
    The dose of propofol used between the two groups will be compared

  • Predictors of sedation related complications [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Patient tolerance as assessed by the patient, endoscopist and CRNAs will be compared between the two groups [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
    The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist and CRNA using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.

  • Frequency of symptoms of nausea and vomiting will be compared between the two groups [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
    The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.


Estimated Enrollment: 400
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol+Benzo/Opioids

If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:

  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
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
Other Names:
  • Benzodiazepine
  • Midazolam
  • Versed
  • Opioid
  • Fentanyl
Active Comparator: Propofol Alone

The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:

  • Induction Dose: 2-2.5 mg/kg
  • Maintenance Dose: 0.1-0.2 mg/kg/min
Drug: Propofol Alone

Recommended Propofol doses before considering crossover:

  • Induction: 2-2.5 mg/kg
  • Maintenance: 0.1-0.2 mg/kg/min
Other Names:
  • Propofol
  • Diprivan
  • 2,6-di-isopropofol

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide informed consent
  • Age greater than or equal to 18 years
  • Presence of at least 1 of the following criteria:

    1. ASA class 3 or higher
    2. BMI of 30 or greater
    3. At risk for OSA (score of 3 or greater on the STOP-BANG screening tool)

Exclusion Criteria:

  • drug allergy to Propofol, Benzodiazepines, or Opioids
  • patients who received Benzodiazepines or Opioids within 24 hours of the procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315158

Contacts
Contact: Faris Murad, M.D. 314-747-2066 fmurad@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Faris Murad, M.D.         
Sub-Investigator: Sachin Wani, M.D.         
Sub-Investigator: Dayna S Early, M.D.         
Sub-Investigator: Riad R Azar, M.D.         
Sub-Investigator: Daniel K Mullady, M.D.         
Sub-Investigator: Steven A Edmundowicz, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Faris Murad, M.D. Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01315158     History of Changes
Other Study ID Numbers: 10-1133
Study First Received: March 11, 2011
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Obstructive Sleep Apnea
Body Mass Index

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Midazolam
Fentanyl
Propofol
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 20, 2014