Propofol vs Propofol + Benzo/Opiates in High Risk Group

NCT01315158 | Terminated Results DMC

• 1 other identifier: 10-1133
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Sleep Apnea, Obstructive; Obesity

Keywords

Obstructive Sleep Apnea; Body Mass Index

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience Airway Maneuvers

  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.

  One day (during procedure)

Secondary Outcomes (8)

• Number of Participants Who Experience Other Sedation Related Complications

  One day (during procedure)

• Compare Propofol Doses Between the Two Groups

  One day (during procedure)

• Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)

  One year

• Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)

  One year

• 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)

  One year

Study Arms (2)

Propofol+Benzo/Opioids

ACTIVE COMPARATOR

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

Propofol Alone

ACTIVE COMPARATOR

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

Interventions

Propofol Alone DRUG

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

Also known as: Propofol, Diprivan, 2,6-di-isopropofol

Propofol Alone

Propofol+Benzo/Opioids DRUG

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

Also known as: Benzodiazepine, Midazolam, Versed, Opioid, Fentanyl

Propofol+Benzo/Opioids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• Age greater than or equal to 18 years
• Presence of at least 1 of the following criteria:
• ASA class 3 or higher
• BMI of 30 or greater
• At risk for OSA (score of 3 or greater on the STOP-BANG screening tool)

You may not qualify if:

• drug allergy to Propofol, Benzodiazepines, or Opioids
• patients who received Benzodiazepines or Opioids within 24 hours of the procedure

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (24)

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  PMID: 18938664 BACKGROUND

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Propofol; Analgesics, Opioid; Benzodiazepines; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Faris Murad, M.D.
• Organization: Washington University School of Medicine

fmurad@northshore.org

Study Officials

• Faris Murad, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 15, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 28, 2016
• Results First Posted: October 28, 2016

Record last verified: 2016-09

Locations

US (1)