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

NCT ID: NCT00762372

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-08-31

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.

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

desflurane

Group Type: EXPERIMENTAL

desflurane

Intervention Type: DRUG

volatile liquid for inhalation

desflurane/N2O

Group Type: EXPERIMENTAL

desflurane/nitrous oxide

Intervention Type: DRUG

volatile liquid for inhalation with gas for inhalation

sevoflurane/N2O

Group Type: ACTIVE_COMPARATOR

sevoflurane/nitrous oxide

Intervention Type: DRUG

volatile liquid for inhalation and gas for inhalation

Interventions

desflurane

volatile liquid for inhalation

Intervention Type: DRUG

desflurane/nitrous oxide

volatile liquid for inhalation with gas for inhalation

Intervention Type: DRUG

sevoflurane/nitrous oxide

volatile liquid for inhalation and gas for inhalation

Intervention Type: DRUG

Other Intervention Names

Suprane; BLM-240; Suprane; BLM-240; N2O; sevoflurane; N2O

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junzo Takeda, MD

Role: PRINCIPAL_INVESTIGATOR

School of Medicine, Keio University

Locations

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

Countries

Japan

Other Identifiers

BLM-240-003

Identifier Type: -

Identifier Source: org_study_id