Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Pulmonary Diseases

Clinical Trial Details

NCT number	NCT01592513
Study type	Interventional
Source	Rabin Medical Center
Contact	Michal Tirosh, MD
Phone	+ 972547930667
Email	michal.tirosh@gmail.com
Status	Recruiting
Phase	N/A
Start date	April 2012
Completion date	October 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00367913` - Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease	Phase 4
Completed	`NCT02146235` - Music Therapy in the Treatment of Chronic Obstructive Pulmonary Disease	N/A
Not yet recruiting	`NCT05452148` - Specific Genotypes/Phenotypes of Pneumocystis Jirovecii in Solid Organ Transplant Recipients: Potential Involvement of Mycophenolic Acid
Not yet recruiting	`NCT05847894` - Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology
Completed	`NCT00719784` - Vibration Response Imaging in the Diagnosis of Pulmonary Disease	N/A
Completed	`NCT03740646` - Pneumocystis Primary Infection in Non-immunosuppressed Infants
Completed	`NCT00284141` - Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma	Phase 2
Completed	`NCT00293514` - TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)	Phase 3
Completed	`NCT02002351` - Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases	N/A
Completed	`NCT00886353` - Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)	Phase 1
Completed	`NCT00320151` - Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases	N/A
Completed	`NCT00395330` - Airways Dysfunction Following WTC Dust Exposure	N/A
Not yet recruiting	`NCT00248391` - The Influence of Feeding Position on Pulmonary Morbidity in Young Children	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.