AnesthesiaPhase 2/3NCT00762372
Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)
A Phase 2/3 study testing desflurane, desflurane/nitrous oxide and sevoflurane/nitrous oxide in people with Anesthesia, run by Baxter Healthcare Corporation at 15 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- desflurane, desflurane/nitrous oxide and sevoflurane/nitrous oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 15 sitesJapan
- Study dates
- Feb 2008to Aug 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Kagoshima University Medical and Dental University
Kagoshima
Kyoto University
Kyoto
Nagoya University
Nagoya
Okayama University
Okayama
Osaka University
Osaka
Sapporo Medical University
Sapporo
Hamamatsu University
Shizuoka
Jikei University
Tokyo
Juntendo University
Tokyo
Keio University
Tokyo
Nippon Medical School
Tokyo
NTT East Japan Kanto Medical
Tokyo
Tokai University
Tokyo
Tokyo University
Tokyo
Tokyo Women's Medical University
Tokyo
About this study
Official title: Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia
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.
Read the 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
- Being tested
- desflurane, desflurane/nitrous oxide, sevoflurane/nitrous oxide
- Keywords
- anesthesia, desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desfluraneDrug
Also called Suprane, BLM-240
volatile liquid for inhalation
desflurane/nitrous oxideDrug
Also called Suprane, BLM-240, N2O
volatile liquid for inhalation with gas for inhalation
sevoflurane/nitrous oxideDrug
Also called sevoflurane, N2O
volatile liquid for inhalation and gas for inhalation
| Study group | Role | What they receive |
|---|---|---|
| desflurane | Experimental | Not described Receives: Drug: desflurane |
| desflurane/N2O | Experimental | Not described Receives: Drug: desflurane/nitrous oxide |
| sevoflurane/N2O | Active comparator | Not described Receives: Drug: sevoflurane/nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Body Movement During Anesthetic Maintenance
The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants With Recall/Memory Issues During Anesthetic Maintenance
The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance
Rescue medication includes vasopressors and depressors.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
"Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to <150 mmHg and heart rate 50 to <100 bpm could be maintained "
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Overall Assessment of Efficacy
Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Time to Extubation
Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation >=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: >=100 mmHg).
Measured: Day 1 (Post-Surgery, from end of study drug inhalation to extubation)
Secondary outcomes (11)
Time to Awakening
Time from the end of study drug inhalation. After the end of inhalation of the study drug, the investigator commanded the patient to open his/her eyes once every minute to check whether he/she awoke and recorded the time of awakening.
Measured: Day 1 (Post-Surgery, from the end of study drug inhalation to awakening)
Time to Stating Birth Date
After extubation, the investigator called and asked the patient to state the birth date once every minute and recorded the time the patient could state the birth date. Time from the end of study drug inhalation.
Measured: Day 1 (Post-Surgery, after extubation)
Time to Reaching an Aldrete Score >=8 (Min)
Score includes a ranking of 0-2 (higher shows improvement) in activity, respiration, circulation, consciousness, and O2 saturation (SpO2). After extubation, the investigator observed the patient's condition every 5 minutes until the Aldrete score reached >=8 and recorded the Aldrete scores at 5-minute intervals.
Measured: Day 1 (Post-Surgery, after extubation)
Time to Clear Consciousness
"Clear consciousness" means that patients responded to investigator's command for physical movement such as "hold my finger tight."
Measured: Day 1 (Post-Surgery, from awakening to before extubation)
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance
BIS is used to monitor depth of anesthesia. The BIS monitor provides a single number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 generally indicates an appropriate level for general anesthesia.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate
Rescue medication can include vasopressors and depressors.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate
Rescue medication can include vasopressors and depressors.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Medication Due to Arrhythmia
Rescue medication can include vasopressors and depressors.
Measured: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance
Measurement by infrared absorption spectrometry. The concentrations of BLM-240 and sevoflurane at the start of inhalation were set at 3% and 1%,respectively (by vaporizer dial setting). Concentrations are monitored to determine which levels keep the patient in stable condition without requiring rescue treatment.
Measured: 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]
Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance
Measurement by infrared absorption spectrometry. Ranges reflecting when concentrations were stable. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).
Measured: 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]
End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia
Successfully maintaining anesthesia is defined as keeping the patient in stable condition (systolic pressure 80 to <150 mmHg and heart rate 50 to <100bpm) without requiring rescue treatment or additional dose of opioid analgesics (<=2 ug/kg/hr).If patient was found to have body movement, recall, or memory during anesthetic maintenance, data for such patient were to be excluded from summary statistic calculation.
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junzo Takeda, MD, Principal investigator, School of Medicine, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762372
- Sponsor's protocol ID
- BLM-240-003
- Status last verified
- Nov 2018
- First submitted
- 26 Sep 2008
- Last updated
- 8 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Clinical Study With BLM-240 in Adult Surgery Patients That Need General Anesthesia
- ClinicalTrials.gov ID
- NCT00762372
- Acronym / sponsor ID
- BLM-240-003
- Conditions
- Anesthesia
- Keywords
- anesthesia, desflurane
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 8 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| desflurane | Experimental | Drug: desflurane |
| desflurane/N2O | Experimental | Drug: desflurane/nitrous oxide |
| sevoflurane/N2O | Active comparator | Drug: sevoflurane/nitrous oxide |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desfluraneAlso: Suprane, BLM-240volatile liquid for inhalation | Drug | desflurane |
| desflurane/nitrous oxideAlso: Suprane, BLM-240, N2Ovolatile liquid for inhalation with gas for inhalation | Drug | desflurane/N2O |
| sevoflurane/nitrous oxideAlso: sevoflurane, N2Ovolatile liquid for inhalation and gas for inhalation | Drug | sevoflurane/N2O |
Primary outcome
Number of Participants With Body Movement During Anesthetic Maintenance
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.
Number of Participants With Recall/Memory Issues During Anesthetic Maintenance
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance.
Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Rescue medication includes vasopressors and depressors.
Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
"Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to <150 mmHg and heart rate 50 to <100 bpm could be maintained "
Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate
Overall Assessment of Efficacy
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.
Time to Extubation
Time frame: Day 1 (Post-Surgery, from end of study drug inhalation to extubation)
Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation >=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: >=100 mmHg).
11 secondary outcomes
Time to Awakening
Time frame: Day 1 (Post-Surgery, from the end of study drug inhalation to awakening)
Time to Stating Birth Date
Time frame: Day 1 (Post-Surgery, after extubation)
Time to Reaching an Aldrete Score >=8 (Min)
Time frame: Day 1 (Post-Surgery, after extubation)
Time to Clear Consciousness
Time frame: Day 1 (Post-Surgery, from awakening to before extubation)
Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Number of Participants Requiring Rescue Medication Due to Arrhythmia
Time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance
Time frame: 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]
Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance
Time frame: 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]
End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia
Time frame: 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]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junzo Takeda, MD principal investigator
School of Medicine, Keio University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing desflurane, desflurane/nitrous oxide and sevoflurane/nitrous oxide in people with Anesthesia, run by Baxter Healthcare Corporation at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Body Movement During Anesthetic Maintenance (time frame: Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019; AzTrials last refreshed its copy on 3 Nov 2026.