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Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762372
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:
The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: desflurane Drug: desflurane/nitrous oxide Drug: sevoflurane/nitrous oxide Phase 2 Phase 3

Detailed Description:
The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: desflurane Drug: desflurane
volatile liquid for inhalation
Other Names:
  • Suprane
  • BLM-240

Experimental: desflurane/N2O Drug: desflurane/nitrous oxide
volatile liquid for inhalation with gas for inhalation
Other Names:
  • Suprane
  • BLM-240
  • N2O

Active Comparator: sevoflurane/N2O Drug: sevoflurane/nitrous oxide
volatile liquid for inhalation and gas for inhalation
Other Names:
  • sevoflurane
  • N2O




Primary Outcome Measures :
  1. Number of Participants With Body Movement During Anesthetic Maintenance [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.

  2. Number of Participants With Recall/Memory Issues During Anesthetic Maintenance [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance.

  3. Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    Rescue medication includes vasopressors and depressors.

  4. Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    "Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to <150 mmHg and heart rate 50 to <100 bpm could be maintained "

  5. Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate

  6. Overall Assessment of Efficacy [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.

  7. Time to Extubation [ Time Frame: Day 1 (Post-Surgery, from end of study drug inhalation to extubation) ]
    Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation >=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: >=100 mmHg).


Secondary Outcome Measures :
  1. Time to Awakening [ Time Frame: Day 1 (Post-Surgery, from the end of study drug inhalation to awakening) ]
    Time from the end of study drug inhalation. After the end of inhalation of the study drug, the investigator commanded the patient to open his/her eyes once every minute to check whether he/she awoke and recorded the time of awakening.

  2. Time to Stating Birth Date [ Time Frame: Day 1 (Post-Surgery, after extubation) ]
    After extubation, the investigator called and asked the patient to state the birth date once every minute and recorded the time the patient could state the birth date. Time from the end of study drug inhalation.

  3. Time to Reaching an Aldrete Score >=8 (Min) [ Time Frame: Day 1 (Post-Surgery, after extubation) ]
    Score includes a ranking of 0-2 (higher shows improvement) in activity, respiration, circulation, consciousness, and O2 saturation (SpO2). After extubation, the investigator observed the patient's condition every 5 minutes until the Aldrete score reached >=8 and recorded the Aldrete scores at 5-minute intervals.

  4. Time to Clear Consciousness [ Time Frame: Day 1 (Post-Surgery, from awakening to before extubation) ]
    "Clear consciousness" means that patients responded to investigator's command for physical movement such as "hold my finger tight."

  5. Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    BIS is used to monitor depth of anesthesia. The BIS monitor provides a single number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 generally indicates an appropriate level for general anesthesia.

  6. Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    Rescue medication can include vasopressors and depressors.

  7. Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    Rescue medication can include vasopressors and depressors.

  8. Number of Participants Requiring Rescue Medication Due to Arrhythmia [ Time Frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours) ]
    Rescue medication can include vasopressors and depressors.

  9. Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance [ Time Frame: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation] ]
    Measurement by infrared absorption spectrometry. The concentrations of BLM-240 and sevoflurane at the start of inhalation were set at 3% and 1%,respectively (by vaporizer dial setting). Concentrations are monitored to determine which levels keep the patient in stable condition without requiring rescue treatment.

  10. Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance [ Time Frame: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, and just before extubation] ]
    Measurement by infrared absorption spectrometry. Ranges reflecting when concentrations were stable. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).

  11. End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia [ Time Frame: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation] ]
    Successfully maintaining anesthesia is defined as keeping the patient in stable condition (systolic pressure 80 to <150 mmHg and heart rate 50 to <100bpm) without requiring rescue treatment or additional dose of opioid analgesics (<=2 ug/kg/hr).If patient was found to have body movement, recall, or memory during anesthetic maintenance, data for such patient were to be excluded from summary statistic calculation.



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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA PS 1-3
  • age: older than 19 y and younger than 70 y
  • undergoing surgery of the thorax(thoracotomy, thoracotomy plus laparotomy, endoscopy; but excluding cardiovascular),abdomen(laparotomy,endoscopy;but excluding cesarean section), joints (including peripheral vessels), back (spine)or neck (neck, throat)
  • willing to be hospitalized for at least 3 days and 2 nights (from the day before surgery to the day after surgery)
  • having given written consent

Exclusion Criteria:

  • need for spinal subarachnoid, epidural or local anesthesia (except local surface or infiltration anesthesia for catheter insertion or use of local anesthetic for testing before inserting epidural catheter for post-surgical pain)
  • contraindication for use of nitrous during surgery
  • anticipated need for postoperative transfer to intensive care unit and receive mechanical pulmonary ventilation
  • BMI of 30 kg/m2 or more
  • serious hepatic, renal, or circulatory disorder (Grade 3 per Notification 80 by MHW, Pharmaceutical Affairs Bureau, Safety Division)
  • uncontrollable hypertension (SBP 160 mmHg or higher while on antihypertensive therapy)
  • emergency surgery
  • history of hypersensitivity to components of sevoflurane, fentanyl, propofol, vecuronium or other anesthetic
  • contraindication to sevoflurane, fentanyl, propofol, or vecuronium
  • exposure or suspected exposure to inhalational halogenated anesthetic within 3 mo prior to consent
  • known or suspected history or family history of malignant hyperthermia
  • considered likely to have difficulty in receiving tracheal intubation due to conditions such as brachygnathia, micrognathia, bucked teeth, articular rheumatism or injury of cervical spine/cervical cord
  • known or suspected to be pregnant or lactating
  • participated in a clinical study within 6 mo prior to consent
  • history of drug dependence
  • history of epilepsy
  • otherwise judged by the investigator to be unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762372


Locations
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Japan
Kagoshima University Medical and Dental University
Kagoshima, Japan
Kyoto University
Kyoto, Japan
Nagoya University
Nagoya, Japan
Okayama University
Okayama, Japan
Osaka University
Osaka, Japan
Sapporo Medical University
Sapporo, Japan
Hamamatsu University
Shizuoka, Japan
Jikei University
Tokyo, Japan
Juntendo University
Tokyo, Japan
Keio University
Tokyo, Japan
Nippon Medical School
Tokyo, Japan
NTT East Japan Kanto Medical
Tokyo, Japan
Tokai University
Tokyo, Japan
Tokyo University
Tokyo, Japan
Tokyo Women's Medical University
Tokyo, Japan
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Junzo Takeda, MD School of Medicine, Keio University
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00762372    
Other Study ID Numbers: BLM-240-003
First Posted: September 30, 2008    Key Record Dates
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019
Last Verified: November 2018
Keywords provided by Baxter Healthcare Corporation:
anesthesia
desflurane
Additional relevant MeSH terms:
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Nitrous Oxide
Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents