NCT01592513

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

March 14, 2012

Last Update Submit

May 3, 2012

Conditions

Pulmonary Diseases

Outcome Measures

Primary Outcomes (1)

  • Total sedative dose in mg.

    Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)

Secondary Outcomes (2)

  • Percentages of patients which developed complications resulting from use of sedatives

    Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure

  • Percentages of awareness during flexible fiberoptic bronchoscopy

    Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)

Study Arms (2)

Control

NO INTERVENTION

BIS monitor

EXPERIMENTAL

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

Interventions

BIS monitorDEVICE

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.

Also known as: BIS monitor by Covidien - aspectmedical
BIS monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Undergoing flexible fiberoptic bronchoscopy for lung tissue biopsy, airway lavage or opening of airway obstruction.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical center

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (10)

  • 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.

    PMID: 15172773BACKGROUND

  • 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.

    PMID: 19443532BACKGROUND

  • 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.

    PMID: 17448053BACKGROUND

  • 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.

    PMID: 23168586BACKGROUND

  • 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.

    PMID: 5423844BACKGROUND

  • 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.

    PMID: 21934290RESULT

  • 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.

    PMID: 21996705RESULT

  • 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.

    PMID: 18337600RESULT

  • I Matot, et al. Sedation in outpatient flexible bronchoscopy: alfentanil-propofol versus Meperidine-Midazolam. Journal of Bronchology & interventional pulmonology 1999; 6:74-77.

    RESULT

  • 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.

    PMID: 21464699RESULT

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Mordechai Kremer, Prof

    Head of pulmonolgy institute, Rabin Medical center

    STUDY DIRECTOR

Central Study Contacts

Michal Tirosh, MD

CONTACT

+ 972547930667michal.tirosh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of pulmonology institute

Study Record Dates

First Submitted

March 14, 2012

First Posted

May 7, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

IL(1)