Lung Disease
Conditions
Brief 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.
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
Interventions
DRUGSedation 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.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percutaneous carbon dioxide tension | From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) | Continues measurements (record every 4 second) |
| oxygen saturation | From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) | Continues measurements (record every 4 second) |
| heart rate | From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) | Continues measurements (record every 4 second) |
| non invasive blood pressure | From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) | every 5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen supplementation | From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) | 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 | From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes) | 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 |
| A questionnaire evaluating pain and discomfort | ~30 minutes after the end of the procedure | 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) |
Countries
Israel
Outcome results
None listed