Status:
COMPLETED
Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Anesthesia
Eligibility:
All Genders
20-69 years
Phase:
PHASE2
PHASE3
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 awakeni...
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 ty...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00762372
Start Date
February 1 2008
End Date
August 1 2008
Last Update
March 8 2019
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Kagoshima University Medical and Dental University
Kagoshima, Japan
2
Kyoto University
Kyoto, Japan
3
Nagoya University
Nagoya, Japan
4
Okayama University
Okayama, Japan