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

Sponsor:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00762372

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Sevoflurane I 653 Nitrous oxide

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
desflurane: Experimental	Drug: desflurane volatile liquid for inhalation
desflurane/N2O: Experimental	Drug: desflurane/nitrous oxide volatile liquid for inhalation with gas for inhalation
sevoflurane/N2O: Active Comparator	Drug: sevoflurane/nitrous oxide volatile liquid for inhalation and gas for inhalation

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
Sapporo Medical University
Sapporo, Japan
Keio University
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
Kagoshima University Medical and Dental University
Kagoshima, Japan
Nippon Medical School
Tokyo, Japan
Hamamatsu University
Shizuoka, Japan
Nagoya University
Nagoya, Japan
Osaka University
Osaka, Japan
Kyoto University
Kyoto, Japan
Okayama University
Okayama, Japan
Jikei 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:	Baxter Healthcare Corporation ( Charles H. McLeskey, MD )
Study ID Numbers:	BLM-240-003
Study First Received:	September 26, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00762372 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Baxter Healthcare Corporation:

anesthesia
desflurane

Additional relevant MeSH terms:

Nitrous Oxide
Hematologic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Sevoflurane
Desflurane
Anesthetics, Inhalation

Analgesics, Non-Narcotic
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Platelet Aggregation Inhibitors
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010