Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy
NCT ID: NCT01592513
Last Updated: 2012-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2012-04-30
2012-10-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing flexible fiberoptic bronchoscopy for lung tissue biopsy, airway lavage or opening of airway obstruction.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Mordechai Kremer
Head of pulmonology institute
Principal Investigators
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Mordechai Kremer, Prof
Role: STUDY_DIRECTOR
Head of pulmonolgy institute, Rabin Medical center
Locations
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Rabin Medical center
Petah Tikva, , Israel
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
I Matot, et al. Sedation in outpatient flexible bronchoscopy: alfentanil-propofol versus Meperidine-Midazolam. Journal of Bronchology & interventional pulmonology 1999; 6:74-77.
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.
Other Identifiers
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rmc116633CTIL
Identifier Type: -
Identifier Source: org_study_id
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