Propofol vs Propofol + Benzo/Opiates in High Risk Group

This study is currently recruiting participants.
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

March 11, 2011
January 31, 2014
January 2011
January 2015   (final data collection date for primary outcome measure)
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.
Frequency of airway maneuvers [ Time Frame: one day (during procedure) ] [ Designated as safety issue: No ]
In high risk patients (meeting at least of 2 of 3 criteria: ASA ≥ 3, BMI ≥ 35, 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.
Complete list of historical versions of study NCT01315158 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 airway maneuvers and other 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.
Not Provided
Not Provided
 
Propofol vs Propofol + Benzo/Opiates in High Risk Group
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

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.

The use of propofol (2,6-di-isopropofol) for sedation during endoscopic procedures has increased in recent years primarily because of its favorable pharmacokinetic profile compared with traditional endoscopic sedation with benzodiazepines and opioids. Propofol has a rapid onset of action (30-45 sec) and short duration of effect (4-8 min). There also are data to support the safe use of propofol for advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS).

There is limited information on the incidence of sedation related complications during advanced endoscopy. Prior studies were limited by controlled patient populations at low risk of developing sedation related cardiopulmonary complications. In a recent study, we defined the frequency of sedation related adverse events including the rate of airway modifications (AMs) with propofol use during advanced endoscopy. From a total of 799 patients, AMs were required in 14.4% of patients, hypoxemia in 12.8%, hypotension in 0.5% and premature termination in 0.6% of the patients. In addition, body mass index (BMI), male sex and American Society of Anesthesiologists (ASA) class of 3 or higher were independent predictors of AMs. Similarly, Wehrmann and Riphaus identified ASA class of 3 or higher, total propofol dose, history of alcohol use and having an emergency endoscopy as independent factors for sedation related complications in patients undergoing advanced procedures.

Given the alarming rates of obesity in the United States, it is believed that the prevalence of obstructive sleep apnea (OSA) may be 10% or higher and in obese adults these numbers could be as high as 25%. Using a previously validated screening tool for OSA [STOP-BANG (SB)], we reported a prevalence rate of patients at risk for OSA of 43.3% in patients undergoing advanced endoscopy procedures. Patients at risk for OSA with a positive SB score (score ≥ 3 of 8) had a higher rate of AMs (20% vs. 6.1%, adjusted relative risk 1.7) and frequency of hypoxemia (12% vs. 5.2%, adjusted relative risk 1.63) compared to those at low risk for OSA. Thus, based on the available data, it appears that ASA class 3 or higher, high BMI, and patients at risk for OSA are factors that place patients undergoing advanced endoscopy procedures at high risk for sedation related complications including airway modifications.

The optimal method for achieving deep sedation in this high risk group of patients is unclear. Propofol may accentuate airway collapse as patients become unresponsive to verbal stimulation (deep sedation). Recent studies suggest that propofol with midazolam and/or opioids may be synergistic in action and therefore the combined application of these drugs may permit smaller doses of each to be used and potentially lead to a reduction in risk of complications and in the dose of propofol needed while retaining the individual advantages of each compound. There is limited data evaluating the synergistic effect of propofol with midazolam and opioids in patients undergoing advanced endoscopy procedures. Ong and colleagues in a randomized controlled trial compared patient sedation and tolerance during ERCP using propofol alone or midazolam, ketamine and pentazocine (sedato-analgesic cocktail) for induction along with propofol for maintenance. Patient tolerance as assessed by visual analog scales by endoscopist and anesthetist were higher in the combination group. Paspatis et al reported higher dosage of intravenous propofol required in patients being sedated with propofol alone compared with that required in patients receiving oral dose of midazolam with propofol for ERCP procedures. In addition, the patients' anxiety levels before the procedure were lower in the combination group. The mean percentage decline in the oxygen saturation during the procedure was significantly greater in propofol alone group. However, these studies excluded patients deemed to be at a high risk for sedation related complications. Patients with ASA class 3 or higher were excluded, the mean BMI was less than 25, and included only patients at average risk for complications associated with sedation.

The significance of synergistic sedation in patients undergoing advanced endoscopy procedures in the high risk patients is unclear. The overall risk of sedation related complications is thought to be higher compared to standard endoscopy due to longer procedure times and the need for relatively deeper levels of sedation.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Obesity
  • 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
  • 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+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
    Intervention: Drug: Propofol+Benzo/Opioids
  • 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
    Intervention: Drug: Propofol Alone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Faris Murad, M.D. 314-747-2066 fmurad@dom.wustl.edu
United States
 
NCT01315158
10-1133
Yes
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Faris Murad, M.D. Washington University School of Medicine
Washington University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP