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Propofol vs Propofol + Benzo/Opiates in High Risk Group

This study has been terminated.
(- The research team is not able to obtain the necessary support to continue the study.)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01315158
First received: March 11, 2011
Last updated: September 8, 2016
Last verified: September 2016
  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
Endpoint Classification: Safety/Efficacy Study
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:
  • Number of Participants Who Experience 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 number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.


Secondary Outcome Measures:
  • Number of Participants Who Experience Other Sedation Related Complications [ Time Frame: One day (during procedure) ] [ Designated as safety issue: No ]
    Compare the number of participants who experience 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 as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Patient Tolerance as Assessed by Endoscopists [ 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 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.

  • Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
    The number of participants who experience 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.


Enrollment: 36
Study Start Date: January 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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   (Adult, Senior)
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

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
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
Results First Received: May 26, 2016
Last Updated: September 8, 2016
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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Propofol
Midazolam
Fentanyl
Analgesics, Opioid
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on December 02, 2016