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Bispectral Index-Guided Sedation for Flexible Bronchoscopy
This study is currently recruiting participants.
Verified by Chang Gung Memorial Hospital, November 2008
Sponsored by: Chang Gung Memorial Hospital
Information provided by: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00789815
  Purpose

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.


Condition Intervention
Flexible Bronchoscopy
Device: Bispectral index guide propofol infusion.
Drug: Clinical-judged midazolam administration

MedlinePlus related topics: Ultrasound
Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Propofol Alfentanil Alfentanil hydrochloride Benzocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Sedation for Flexible Bronchoscopy and Real Time Endobronchial Ultrasound -A Comparison Between Bispectral Index-Guided Sedation and Conventional Sedation

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 1. The global tolerance of patients about flexible bronchoscopy (FB). 2. The cooperation of patients during FB from the view of the bronchoscopist. [ Time Frame: As patients are recovery. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. The adverse events during FB. 2. The induction time, recovery time from sedation and patients' perception about symptoms during FB. [ Time Frame: At the end of procedures. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
BIS-guided propofol infusion.
Device: Bispectral index guide propofol infusion.

Induction:

Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70.

Maintenance:

Propofol infusion to maintain BIS around 65~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough.

2: Active Comparator
Clinical-judged midazolam administration.
Drug: Clinical-judged midazolam administration

Induction:

Alfentanil as study arm. 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.


Detailed Description:

It is well known that patients undergoing bronchoscopy could be less suffering and the procedures could be carried on more smoothly if the patients have adequate sedation and analgesia. The preferred sedative and analgesic drugs are Midazolam and opioid, like Alfentanil or Morphine, which were titrated according to physicians' judgment on patients' clinical responsiveness. However, due to the pharmacokinetic characteristic of midazolam while used in intravenous injection (onset time 4-6 minutes, effective time 2-4 hours), the effective onset time may be too slow for repeated injection while patients already suffered from the bronchoscopic procedure. It is also noted that when over-sedation occurred the side effects like apnea/hypopnea, hypoxemia, and hypotension could last from dozen minutes to few hours. Although events mentioned above could be handled properly under experienced medical staff, it is still very difficult to predict the oncoming events as the pharmacokinetic effect is variant individually. Ideally, it will be more safe and efficient, during invasive procedure like bronchoscope, if the sedative drug could be onset or vanish fast and the drug effect could be titrated with an objective device directly monitoring the depth of sedation or anesthesia.

Propofol is a short-acting intravenous sedative agent used for the induction of general anesthesia for children and adults; maintenance of general anesthesia; and sedation in medical contexts, such as intensive care unit (ICU) sedation for intubated, mechanically ventilated adults, and in procedures such as colonoscopy. Its mechanism of action is uncertain, but it is postulated that its primary effect may be potentiation of the GABA-A receptor, possibly by slowing the channel closing time. It has a fast onset time (1~2 minutes) but a short working duration (8~10 minutes), which vanished fast after stop administration. Bispectral Index (BIS), an non-invasive neurophysiologic monitor instrument, can transform the EEG and EMG of the patient to a continual numeral, ranging from 0 to 99, which provides a direct and real-time sedative depth monitor. A BIS value of 0 equals EEG silence, near 100 is the expected value in a fully awake adult, and below70 indicated the patient lose explicit memory recall but still has the ability to maintain his own vital signs.

In this study, we design a sedative technique for bronchoscopy, a BIS-guided propofol administration, to compare with the traditional sedative technique, clinical-judged midazolam administration. Through the combination of the advantages of unique pharmacokinetics of propofol and real time monitor of sedative level from BIS, we hope to provide patients undergoing bronchoscopy a more satisfied and safety sedative procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789815

Contacts
Contact: Ting-Yu Lin, MD 886-3-3281200 ext 5108 yuebaoyuebao@yahoo.com.tw

Locations
Taiwan
Division of Thoracic Medicine, Chang Gung Memorial Hospital Recruiting
5. Fu-Hsing street.Gueishan Township, Taoyuan, Taiwan, 333
Contact: Ting-Yu Lin, MD     886-3-3281200 ext 5108     yuebaoyuebao@yahoo.com.tw    
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ting-Yu Lin, MD Division of Thoracic Medicine, Chang Gung Memorial hospital
  More Information

Study ID Numbers: 97-0257B
Study First Received: November 10, 2008
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00789815  
Health Authority: Taiwan: Department of Health;   Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
flexible bronchoscopy
sedation
bispectral index

Study placed in the following topic categories:
Benzocaine
Alfentanil
Propofol
Midazolam

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009