Pulmonary Diseases
Conditions
Brief summary
In this research, the investigators will asses the effect of BIS monitoring on propofol usage during elective flexible fiberoptic bronchoscopy. The investigators will examine whether use of BIS monitor enables reduction of sedative dose during bronchoscopy. The investigators will also examine whether administration of lower total sedative dose enables prevention of possible complications.
Detailed description
During flexible fiberoptic bronchoscopy (FFP) a narrow optic tube is inserted via the mouth or nose into the airways. This allows direct visualization of the airways as well as taking different samples. In addition, this procedure allows opening of airway obstruction. Administration of sedation during FFP is important, since this diminishes patient discomfort and body movements. It also lessens the untoward physiologic response to airway manipulation. In addition, patients requiring repeated examinations may refuse if they have suffered an unpleasant experience. FFP is usually a brief procedure (several minutes up to an hour). Therefore, it is advantageous to use short acting drugs in order to shorten the prolonged post procedural monitoring and allow rapid patient discharge. Several clinical trials have shown the superiority of propofol over midazolam for sedation during bronchoscopy regarding recovery of alertness, memory & motor function. Propofol is a sedative-hypnotic with rapid onset and short duration. Using propofol, one can achieve rapid onset of sedation and faster recovery. Propofol given in boluses of 10-20 mg was found as an effective dose to reach BIS target values. Awareness is the postoperative recollection of events occurring during general anesthesia. BIS is a monitor of anesthetic depth approved by the FDA. It incorporates time-domain, frequency-domain and bi-spectral analysis of the EEG. This analysis is displayed as a dimensionless number between zero (deep anesthesia) and 100 (awake). BIS values between 80-90 represent values corresponding to light/moderate sedation
Interventions
DEVICEBIS monitor
BIS is a monitor of anesthetic depth approved by the FDA. It incorporates time-domain, frequency-domain and bi-spectral analysis of the EEG. This analysis is displayed as a dimensionless number between zero (deep anesthesia) and 100 (awake). BIS values between 80-90 represent values corresponding to light/moderate sedation. BIS is a valuable tool for assessing the depth of sedation and guiding the administration of sedative drugs.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old * Undergoing flexible fiberoptic bronchoscopy for lung tissue biopsy, airway lavage or opening of airway obstruction.
Exclusion criteria
* Patient refusal/ inability to sign informed consent. * Age under 18 years of age. * Ventilated patients (via endotracheal tube or tracheostomy). * Known allergy for one of the anesthetic drugs. * Patients who suffered a stroke and/or have other neurological diseases. * Hemodynamically unstable patients (SBP below 90mmHg or above 180mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total sedative dose in mg. | Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of patients which developed complications resulting from use of sedatives | Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure | The investigators will assess the occurrence of the following complications: hemodynamic instability, hypoxemia, respiratory depression. |
| Percentages of awareness during flexible fiberoptic bronchoscopy | Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) | — |
Countries
Israel
Contacts
Primary ContactMichal Tirosh, MD
Outcome results
None listed