Clinical trial NCT00789815: Bispectral Index-guided Sedation for Flexible Bronchoscopy
Official title: Sedation for Flexible Bronchoscopy and Real Time Endobronchial Ultrasound -A Comparison Between Bispectral Index-guided Sedation and Conventional Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Flexible Bronchoscopy
Keywords: flexible bronchoscopy
sedation
bispectral index
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 Gamma-Amino Butyric Acid-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 electroencephalogram (EEG) and electromyography 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 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.

Primary outcomes:
measure: The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy
timeFrame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
measure: The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy
timeFrame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
measure: The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale
timeFrame: After patients recovered orientation and before they leaved the scope room.
Secondary outcomes:
measure: The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy
timeFrame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
measure: The Number of Participants Causing Any Procedure Interference by Cough
timeFrame: From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
measure: The Recovery Time to Orientation
timeFrame: After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation
measure: The Recovery Time to Ambulation
timeFrame: After the bronchoscopy
measure: Patients Willing Return if Repeated Bronchoscopy is Indicated.
timeFrame: After patients recovered orientation and before they leaved the scope room.
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Division of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Division of Thoracic Medicine, Chang Gung Memorial hospital
name: Ting-Yu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.