Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Chang Gung Memorial Hospital |
---|---|
Information provided by: | Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00789815 |
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 |
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 |
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. |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ting-Yu Lin, MD | 886-3-3281200 ext 5108 | yuebaoyuebao@yahoo.com.tw |
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 |
Principal Investigator: | Ting-Yu Lin, MD | Division of Thoracic Medicine, Chang Gung Memorial hospital |
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 |
flexible bronchoscopy sedation bispectral index |
Benzocaine Alfentanil Propofol Midazolam |
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 |