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. Identifier: NCT00762372
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : August 18, 2011
Information provided by:
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.

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

MedlinePlus related topics: Anesthesia

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. Anesthetic effectiveness (presence/absence of body movement, presence/absence of awakening, presence/absence of need for rescue medication, control of BP/heart rate, presence/absence of intraoperative recall) [ Time Frame: anesthesia maintenance ]
  2. Time to extubation [ Time Frame: end of anesthesia ]

Secondary Outcome Measures :
  1. Times to awakening, stating birth date, reaching Aldrete score of 8 [ Time Frame: end of anesthesia ]
  2. Changes in BIS [ Time Frame: anesthesia maintenance ]
  3. Need for rescue treatment [ Time Frame: anesthesia maintenance ]
  4. Changes in end-tidal and inspired concentrations [ Time Frame: anesthesia maintenance ]
  5. desflurane (BLM-240) concentrations that maintain anesthesia and patient stability without rescue medication for blood pressure or anesthesia [ Time Frame: anesthesia maintenance ]

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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

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 identifier (NCT number): NCT00762372

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
Principal Investigator: Junzo Takeda, MD School of Medicine, Keio University

Responsible Party: Charles H. McLeskey, MD, Baxter Healthcare Corporation Identifier: NCT00762372     History of Changes
Other Study ID Numbers: BLM-240-003
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by Baxter Healthcare Corporation:

Additional relevant MeSH terms:
Nitrous Oxide
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents