Bispectral Index-guided Sedation for Flexible Bronchoscopy

NCT00789815 | Completed Phase 4 Results

• 1 other identifier: 97-0257B
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time endobronchial ultrasound, the complexity and duration of procedures are increasing. So, adequate sedation and analgesia is important for both patients and bronchoscopist. Clinical-judged midazolam administration is the current standard. However, midazolam is difficult to titrated and the clinical observations are not reliable sedative indices. Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a real time monitor of depth-of-sedation, has been applied in general anesthesia. We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of advantages of propofol and BIS, we hope to provide patients a more tolerable and safety sedation for bronchoscopy.

Conditions

Flexible Bronchoscopy

Keywords

flexible bronchoscopy; sedation; bispectral index

Outcome Measures

Primary Outcomes (3)

• The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy

  The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.

  From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth

• The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy

  The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.

  From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth

• The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale

  The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).

  After patients recovered orientation and before they leaved the scope room.

Secondary Outcomes (5)

• The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy

  From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth

• The Number of Participants Causing Any Procedure Interference by Cough

  From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth

• The Recovery Time to Orientation

  After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation

• The Recovery Time to Ambulation

  After the bronchoscopy

• Patients Willing Return if Repeated Bronchoscopy is Indicated.

  After patients recovered orientation and before they leaved the scope room.

Study Arms (2)

BIS-guided propofol infusion

ACTIVE COMPARATOR

In the study group, induction was started using alfentanil 4\~5μg/kg bolus following repeated propofol boluses (0.5\~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3\~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.

Device: Bispectral index guide propofol infusion

Clinical-judged midazolam administration

ACTIVE COMPARATOR

In the control group, induction was started using alfentanil 4\~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/2min until conscious sedation was achieved

Drug: Clinical-judged midazolam administration

Interventions

Bispectral index guide propofol infusion DEVICE

Induction: Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70. Maintenance: Propofol infusion (3\~12 mg/kg/hour) to maintain BIS around 65\~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough.

Also known as: BIS-guided profopol infusion

BIS-guided propofol infusion

Clinical-judged midazolam administration DRUG

Induction: Alfentanil: 5μg/kg slowly push. Midazolam: 2 mg slowly push followed by increments of 2 mg/ 2min till OAA/S\* 2\~3. Maintenance: Midazolam: 2 mg/ 2min prn to keep OAA/S\* 2\~3 or if intolerance of procedure. Alfentanil as study arm. \*Observer's assessment of alertness/sedation (OAA/S): Class 5: Responds readily to name spoken in normal tone. Class 4: Lethargic response to name called in normal tone. Class 3: Responds only to name called loudly. Class 2: Responds only to shaking. Class 1: No response to shaking.

Clinical-judged midazolam administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (\>18 years old) requiring elective flexible bronchoscopy or Real time endobronchial ultrasound with transbronchial needle aspiration.

You may not qualify if:

• American Society of Anesthesiologists classification of physical status 4 and 5, including hepatic or renal failure, severe obstructive sleep apnea and severe chronic obstructive pulmonary disease.
• Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
• Allergic history to study drugs.
• A history of glaucoma in the midazolam arm.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.

  PMID: 22132138 DERIVED

Limitations and Caveats

The bronchoscopists were not blinded to sedative procedures. It was difficult to accomplish totally blind conditions. The bronchoscopist would realize which protocol it was when only observing responses of the investigator.

Results Point of Contact

• Title: Ting-Yu Lin
• Organization: Chung Gung Memorial Hospital

yuebaoyuebao@yahoo.com.tw

886 3 3281200

Study Officials

• Ting-Yu Lin, MD

  Division of Thoracic Medicine, Chang Gung Memorial hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 13, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 8, 2017
• Results First Posted: April 20, 2010

Record last verified: 2010-04

Locations

TW (1)