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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00762372
First received: September 26, 2008
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Anesthesia
 Drug: desflurane
Drug: desflurane/nitrous oxide
Drug: sevoflurane/nitrous oxide
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Time to extubation [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Times to awakening, stating birth date, reaching Aldrete score of 8 [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • Changes in BIS [ Time Frame: anesthesia maintenance ] [ Designated as safety issue: No ]
  • Need for rescue treatment [ Time Frame: anesthesia maintenance ] [ Designated as safety issue: No ]
  • Changes in end-tidal and inspired concentrations [ Time Frame: anesthesia maintenance ] [ Designated as safety issue: No ]
  • desflurane (BLM-240) concentrations that maintain anesthesia and patient stability without rescue medication for blood pressure or anesthesia [ Time Frame: anesthesia maintenance ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762372

Locations
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
Nippon Medical School
Tokyo, Japan
Tokyo Women's Medical University
Tokyo, Japan
Tokyo University
Tokyo, Japan
Juntendo University
Tokyo, Japan
NTT East Japan Kanto Medical
Tokyo, Japan
Tokai University
Tokyo, Japan
Keio University
Tokyo, Japan
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Junzo Takeda, MD School of Medicine, Keio University
  More Information

No publications provided

Responsible Party: Charles H. McLeskey, MD, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00762372     History of Changes
Other Study ID Numbers: BLM-240-003
Study First Received: September 26, 2008
Last Updated: August 16, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Baxter Healthcare Corporation:
anesthesia
desflurane

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

ClinicalTrials.gov processed this record on May 19, 2013