Clinical trial NCT01592513: Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy
Official title: Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Diseases
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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).

Primary outcomes:
measure: Total sedative dose in mg.
timeFrame: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)
Secondary outcomes:
measure: Percentages of patients which developed complications resulting from use of sedatives
timeFrame: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure
measure: Percentages of awareness during flexible fiberoptic bronchoscopy
timeFrame: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical center
Study officials:
affiliation: Head of pulmonolgy institute, Rabin Medical center
name: Mordechai Kremer, Prof
role: STUDY_DIRECTOR
References:
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citation: Tschopp JM, Purek L, Frey JG, Schnyder JM, Diaper J, Cartier V, Licker M. Titrated sedation with propofol for medical thoracoscopy: a feasibility and safety study. Respiration. 2011;82(5):451-7. doi: 10.1159/000329438. Epub 2011 Oct 13.
citation: Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
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