Propofol Versus Midazolam+Alfentanil for Sedation During Bronchoscopy: Comparison by Cutaneous Carbon Dioxide Tension
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Disease
Intervention: Sedation with Propofol or Midazolam+Alfentanil for FFB (Drug)
Phase: N/A
Status: Completed
Sponsored by: Rabin Medical Center Official(s) and/or principal investigator(s): Mordechai R Kramer, MD,Professor, Principal Investigator, Affiliation: Head, Pulmonary Institute , Rabin Medical center, Beilinson Hospital, Petach Tikva, 49100 Israel
Summary
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.
Clinical Details
Official title: Propofol Versus Midazolam Plus Alfentanil for Sedation During Flexible Bronchoscopy: Respiratory Depression Comparison Inspected by Cutaneous Carbon Dioxide Tension Level
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percutaneous carbon dioxide tensionoxygen saturation heart rate non invasive blood pressure
Secondary outcome: A questionnaire evaluating pain and discomfortOxygen supplementation Naso/oropharyngeal tube insertion
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Rabin Medical center, Beilinson Hospital, Petach Tikva 49100, Israel
Additional Information
Starting date: April 2010
Last updated: February 2, 2011
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