Propofol Versus Midazolam+Alfentanil for Sedation During Bronchoscopy: Comparison by Cutaneous Carbon Dioxide Tension

This study has been completed.
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01289327
First received: January 16, 2011
Last updated: February 2, 2011
Last verified: December 2010
  Purpose

Although propofol is a popular agent for sedation during flexible bronchoscopy, some clinicians have raised concerns that it may cause greater respiratory drive reduction than more common drugs. However, this factor is difficult to accurately examine with pulse oximetry. The introduction of a novel device that noninvasively measures carbon dioxide (CO2) levels can help to resolve this controversy. The aim of this study is to evaluate the safety of conscious sedation with midazolam+alfentanil compared to propofol.


Condition Intervention
Lung Disease
Drug: Sedation with Propofol or Midazolam+Alfentanil for FFB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Propofol Versus Midazolam Plus Alfentanil for Sedation During Flexible Bronchoscopy: Respiratory Depression Comparison Inspected by Cutaneous Carbon Dioxide Tension Level

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Percutaneous carbon dioxide tension [ Time Frame: From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) ] [ Designated as safety issue: Yes ]
    Continues measurements (record every 4 second)

  • oxygen saturation [ Time Frame: From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) ] [ Designated as safety issue: Yes ]
    Continues measurements (record every 4 second)

  • heart rate [ Time Frame: From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) ] [ Designated as safety issue: Yes ]
    Continues measurements (record every 4 second)

  • non invasive blood pressure [ Time Frame: From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) ] [ Designated as safety issue: Yes ]
    every 5 minutes


Secondary Outcome Measures:
  • A questionnaire evaluating pain and discomfort [ Time Frame: ~30 minutes after the end of the procedure ] [ Designated as safety issue: No ]
    A questionnaire evaluating pain and discomfort by Visual Analog Scale was completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure)

  • Oxygen supplementation [ Time Frame: From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) ] [ Designated as safety issue: Yes ]

    Significant hypoxemia, defined as functional SpO2 of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1.

    The percentage of patients who needed supplemental oxygen was evaluated


  • Naso/oropharyngeal tube insertion [ Time Frame: From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) ] [ Designated as safety issue: Yes ]

    Significant hypoxemia, defined as functional SpO2 of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1

    The percentage of patients who needed Naso/oropharyngeal tube insertion was evaluated



Enrollment: 115
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol Drug: Sedation with Propofol or Midazolam+Alfentanil for FFB
Sedation was started with intravenous injection of a bolus of 2-4 mg midazolam and 0.5 mg alfentanil or 20-50 mg propofol. It was maintained with intermittent boluses of 1-3 mg intravenous midazolam or 0.5 mg intravenous alfentanil, according to clinical judgment, or with boluses of 10-20 mg intravenous propofol, administered at short intervals (~2 minutes) or according to clinical judgment.
Other Names:
  • diprivan
  • midazolam
  • alfentanil
Active Comparator: midazolam+alfentanil Drug: Sedation with Propofol or Midazolam+Alfentanil for FFB
Sedation was started with intravenous injection of a bolus of 2-4 mg midazolam and 0.5 mg alfentanil or 20-50 mg propofol. It was maintained with intermittent boluses of 1-3 mg intravenous midazolam or 0.5 mg intravenous alfentanil, according to clinical judgment, or with boluses of 10-20 mg intravenous propofol, administered at short intervals (~2 minutes) or according to clinical judgment.
Other Names:
  • diprivan
  • midazolam
  • alfentanil

Detailed Description:

Methods: The study group included 115 patients undergoing flexible fiberoptic bronchoscopy(FFB). Patients were randomly assigned by a computer before the procedure to receive sedation with midazolam+alfentanil or propofol. Local anesthesia was induced by application of 2% lidocaine to the oropharynx. Sedation was started with intravenous injection of a bolus of 2-4 mg midazolam and 0.5 mg alfentanil or 20-50 mg propofol. It was maintained with intermittent boluses of 1-3 mg intravenous midazolam or 0.5 mg intravenous alfentanil, according to clinical judgment, or with boluses of 10-20 mg intravenous propofol, administered at short intervals (~2 minutes) or according to clinical judgment.

In all cases, monitoring included continuous electrocardiography, pulse oximetry, and automated noninvasive blood pressure recordings every 5 minutes. In addition, percutaneous carbon dioxide tension (PcCO2) was measured with a cutaneous digital sensor (Sentec AG, Therwil, Switzerland) that was placed on the earlobe prior to the procedure. It was removed when the patient left the bronchoscopy suite.

During the procedure, all patients received supplemental nasal oxygen at 2-5 L min-1. Significant hypoxemia, defined as functional oxygen saturation (SpO2) of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1. The duration of bronchoscopy was calculated from the administration of sedation until the flexible bronchoscope was removed from the tracheobronchial tree.

Percutaneous carbon dioxide tension, blood oxygenation, heart rate, and blood pressure were compared between the groups.

A questionnaire evaluating pain and discomfort by Visual Analog Scale was completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure

  Eligibility

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

Inclusion Criteria:

  • The study group consisted of patients scheduled for flexible bronchoscopy under local anesthesia with sedation at a tertiary medical center.

Exclusion Criteria:

  • Inability or refusal to provide informed consent, age less than 18 years, bronchoscopy through an artificial airway, and allergy to soya or to one of the sedative drugs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289327

Locations
Israel
Rabin Medical center, Beilinson Hospital
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordechai R Kramer, MD,Professor Head, Pulmonary Institute , Rabin Medical center, Beilinson Hospital, Petach Tikva, 49100 Israel
  More Information

No publications provided

Responsible Party: Mordechai R Kramer, MD,Professor, Rabin Medical Center/Clalit
ClinicalTrials.gov Identifier: NCT01289327     History of Changes
Other Study ID Numbers: 5634
Study First Received: January 16, 2011
Last Updated: February 2, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Lung Diseases
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders
Alfentanil
Midazolam
Propofol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014