Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

Pulmonary Diseases Clinical Trial

Official title:

Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01592513
• Other study ID #: rmc116633CTIL
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2012
• Last updated: May 3, 2012
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: May 2012
• Source: Rabin Medical Center
• Contact: Michal Tirosh, MD
• Phone: + 972547930667
• Email: michal.tirosh[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Pulmonary Diseases

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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/NEJMoa0 — View 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. — View 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. — View 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. — View 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. — View Citation

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sedative dose in mg.		Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)	No
Secondary	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.	Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure	Yes
Secondary	Percentages of awareness during flexible fiberoptic bronchoscopy		Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)	No