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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
Results First Received: May 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Sleep Apnea, Obstructive
Obesity
Interventions: Drug: Propofol Alone
Drug: Propofol+Benzo/Opioids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

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

    a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg

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

Propofol Alone: Recommended Propofol doses before considering crossover:

  • Induction: 2-2.5 mg/kg
  • Maintenance: 0.1-0.2 mg/kg/min

Participant Flow:   Overall Study
    Propofol+Benzo/Opioids   Propofol Alone
STARTED   17   19 
COMPLETED   17   19 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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

    a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg

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

Propofol Alone: Recommended Propofol doses before considering crossover:

  • Induction: 2-2.5 mg/kg
  • Maintenance: 0.1-0.2 mg/kg/min
Total Total of all reporting groups

Baseline Measures
   Propofol+Benzo/Opioids   Propofol Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   19   36 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   14   29 
>=65 years   2   5   7 
Gender 
[Units: Participants]
     
Female   9   5   14 
Male   8   14   22 
Region of Enrollment 
[Units: Participants]
     
United States   17   19   36 


  Outcome Measures
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1.  Primary:   Number of Participants Who Experience Airway Maneuvers   [ Time Frame: One day (during procedure) ]

2.  Secondary:   Number of Participants Who Experience Other Sedation Related Complications   [ Time Frame: One day (during procedure) ]

3.  Secondary:   Compare Propofol Doses Between the Two Groups   [ Time Frame: One day (during procedure) ]

4.  Secondary:   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 ]

5.  Secondary:   Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)   [ Time Frame: One year ]

6.  Secondary:   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 ]

7.  Secondary:   Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication   [ Time Frame: One year ]

8.  Secondary:   Patient Tolerance as Assessed by Endoscopists   [ Time Frame: 24-48 hours ]

9.  Secondary:   Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups   [ Time Frame: 24-48 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Faris Murad, M.D.
Organization: Washington University School of Medicine
e-mail: fmurad@northshore.org


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