Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01592513
First received: March 14, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Pulmonary Diseases
Device: BIS monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Total sedative dose in mg. [ Time Frame: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentages of patients which developed complications resulting from use of sedatives [ Time Frame: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure ] [ Designated as safety issue: Yes ]
    The investigators will assess the occurrence of the following complications: hemodynamic instability, hypoxemia, respiratory depression.

  • Percentages of awareness during flexible fiberoptic bronchoscopy [ Time Frame: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: BIS monitor

Patients in this group will be monitored by BIS (placement of an electrode over the forehead before sedation).

Patients in this group will receive propofol (boluses of 10-20 mg) to reach a BIS target value of 80-90.

Device: BIS 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.

Other Name: BIS monitor by Covidien - aspectmedical

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592513

Contacts
Contact: Michal Tirosh, MD + 972547930667 michal.tirosh@gmail.com

Locations
Israel
Rabin Medical center Recruiting
Petah Tikva, Israel, 49100
Sub-Investigator: Michal Tirosh, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Mordechai Kremer, Prof Head of pulmonolgy institute, Rabin Medical center
  More Information

Publications:
U Carmi, et al. Propofol safety in bronchoscopy: prospective randomized trial using transcutaneous carbon dioxide tension monitoring. Respiration 2011; 82(6):515-21.
J-M Tschopp, et al. Titrated sedation with propofol for medical thoracoscopy: A feasibility and safety study. Respiration 2011; 82:451-457.
George A. Mashour et al. Intraoperative awareness. From neurobiology to clinical practice. Anesthesiology 2011; 114 (5): 1218-1233.
S Yamamoto et al. Bispectral index monitoring of Midazolam sedation during flexible bronchoscopy. J of intervent Pulmonol 2009; 16(4): 241-244.

Responsible Party: Mordechai Kremer, Head of pulmonology institute, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01592513     History of Changes
Other Study ID Numbers: rmc116633CTIL
Study First Received: March 14, 2012
Last Updated: May 3, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014