Clinical trial NCT00762372: Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)
Official title: Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Keywords: anesthesia
desflurane
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Body Movement During Anesthetic Maintenance
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants With Recall/Memory Issues During Anesthetic Maintenance
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Overall Assessment of Efficacy
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Time to Extubation
timeFrame: Day 1 (Post-Surgery, from end of study drug inhalation to extubation)
Secondary outcomes:
measure: Time to Awakening
timeFrame: Day 1 (Post-Surgery, from the end of study drug inhalation to awakening)
measure: Time to Stating Birth Date
timeFrame: Day 1 (Post-Surgery, after extubation)
measure: Time to Reaching an Aldrete Score >=8 (Min)
timeFrame: Day 1 (Post-Surgery, after extubation)
measure: Time to Clear Consciousness
timeFrame: Day 1 (Post-Surgery, from awakening to before extubation)
measure: Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Number of Participants Requiring Rescue Medication Due to Arrhythmia
timeFrame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
measure: Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance
timeFrame: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation]
measure: Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance
timeFrame: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, and just before extubation]
measure: End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia
timeFrame: Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation]
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Kagoshima University Medical and Dental University
city: Kyoto
country: Japan
facility: Kyoto University
city: Nagoya
country: Japan
facility: Nagoya University
city: Okayama
country: Japan
facility: Okayama University
city: Osaka
country: Japan
facility: Osaka University
city: Sapporo
country: Japan
facility: Sapporo Medical University
city: Shizuoka
country: Japan
facility: Hamamatsu University
city: Tokyo
country: Japan
facility: Jikei University
city: Tokyo
country: Japan
facility: Juntendo University
city: Tokyo
country: Japan
facility: Keio University
city: Tokyo
country: Japan
facility: Nippon Medical School
city: Tokyo
country: Japan
facility: NTT East Japan Kanto Medical
city: Tokyo
country: Japan
facility: Tokai University
city: Tokyo
country: Japan
facility: Tokyo University
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
Study officials:
affiliation: School of Medicine, Keio University
name: Junzo Takeda, MD
role: PRINCIPAL_INVESTIGATOR
References: