Propofol Versus Midazolam+Alfentanil for Sedation During Bronchoscopy: Comparison by Cutaneous Carbon Dioxide Tension
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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 |
- 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
- 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:
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| 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:
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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 |
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| Israel | |
| Rabin Medical center, Beilinson Hospital | |
| Petach Tikva, Israel, 49100 | |
| 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 May 21, 2013