Clinical Trials Logo

Clinical Trial 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 Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01289327
Study type Interventional
Source Rabin Medical Center
Contact
Status Completed
Phase N/A
Start date April 2010
Completion date January 2011

See also
  Status Clinical Trial Phase
Completed NCT02217423 - Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy N/A
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT02345135 - Susceptibility to Infections in Ataxia Telangiectasia N/A
Completed NCT01679301 - Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator N/A
Terminated NCT00966823 - Fetal Tracheal Balloon Study in Diaphragmatic Hernia Phase 2
Completed NCT00139152 - Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair Phase 4
Completed NCT00052052 - An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Recruiting NCT02963467 - Effect of Smoking on Ventilation-Perfusion Ratio N/A
Recruiting NCT02965300 - The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis N/A
Enrolling by invitation NCT02946658 - Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders Phase 1/Phase 2
Recruiting NCT02913365 - Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis N/A
Completed NCT01952002 - Clinical Safety for the Inspiratory Muscle Training N/A
Completed NCT01735526 - Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation N/A
Recruiting NCT01450644 - Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease Phase 2
Completed NCT01215279 - AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD) Phase 2
Completed NCT01153321 - Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Completed NCT00837681 - Pulmonary Complications of Hematopoietic Stem Cell Transplantation N/A
Completed NCT02055222 - Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
Completed NCT01222442 - To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart Phase 1