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Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

Primary Purpose

Pulmonary Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
BIS monitor
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Rabin Medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

BIS monitor

Arm Description

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.

Outcomes

Primary Outcome Measures

Total sedative dose in mg.

Secondary Outcome Measures

Percentages of patients which developed complications resulting from use of sedatives
The investigators will assess the occurrence of the following complications: hemodynamic instability, hypoxemia, respiratory depression.
Percentages of awareness during flexible fiberoptic bronchoscopy

Full Information

First Posted
March 14, 2012
Last Updated
May 3, 2012
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01592513
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
BIS monitor
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BIS monitor
Other Intervention Name(s)
BIS monitor by Covidien - aspectmedical
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total sedative dose in mg.
Time Frame
Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)
Secondary Outcome Measure Information:
Title
Percentages of patients which developed complications resulting from use of sedatives
Description
The investigators will assess the occurrence of the following complications: hemodynamic instability, hypoxemia, respiratory depression.
Time Frame
Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure
Title
Percentages of awareness during flexible fiberoptic bronchoscopy
Time Frame
Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Tirosh, MD
Phone
+ 972547930667
Email
michal.tirosh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai Kremer, Prof
Organizational Affiliation
Head of pulmonolgy institute, Rabin Medical center
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Tirosh, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15172773
Citation
Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
Results Reference
background
PubMed Identifier
19443532
Citation
Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.
Results Reference
background
PubMed Identifier
17448053
Citation
Bould MD, Mahtani DG, Davies R, Roughton M, Hunter DN, Kelleher A. Bispectral index values during elective rigid bronchoscopy: a prospective observational pilot study. Anaesthesia. 2007 May;62(5):438-45. doi: 10.1111/j.1365-2044.2007.04986.x.
Results Reference
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PubMed Identifier
23168586
Citation
Yamamoto S, Igarashi T, Tetsuka K, Endo S. Bispectral index monitoring of midazolam sedation during flexible bronchoscopy. J Bronchology Interv Pulmonol. 2009 Oct;16(4):241-4. doi: 10.1097/LBR.0b013e3181bb781f.
Results Reference
background
PubMed Identifier
5423844
Citation
Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970 Jun;42(6):535-42. doi: 10.1093/bja/42.6.535. No abstract available.
Results Reference
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PubMed Identifier
21934290
Citation
Carmi U, Kramer MR, Zemtzov D, Rosengarten D, Fruchter O. Propofol safety in bronchoscopy: prospective randomized trial using transcutaneous carbon dioxide tension monitoring. Respiration. 2011;82(6):515-21. doi: 10.1159/000331506. Epub 2011 Sep 16.
Results Reference
result
PubMed Identifier
21996705
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.
Results Reference
result
PubMed Identifier
18337600
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.
Results Reference
result
Citation
I Matot, et al. Sedation in outpatient flexible bronchoscopy: alfentanil-propofol versus Meperidine-Midazolam. Journal of Bronchology & interventional pulmonology 1999; 6:74-77.
Results Reference
result
PubMed Identifier
21464699
Citation
Mashour GA, Orser BA, Avidan MS. Intraoperative awareness: from neurobiology to clinical practice. Anesthesiology. 2011 May;114(5):1218-33. doi: 10.1097/ALN.0b013e31820fc9b6.
Results Reference
result

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Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

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