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

November 13, 2018 updated by: Baxter Healthcare Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima, Japan
        • Kagoshima University Medical and Dental University
      • Kyoto, Japan
        • Kyoto University
      • Nagoya, Japan
        • Nagoya University
      • Okayama, Japan
        • Okayama University
      • Osaka, Japan
        • Osaka University
      • Sapporo, Japan
        • Sapporo Medical University
      • Shizuoka, Japan
        • Hamamatsu University
      • Tokyo, Japan
        • Juntendo University
      • Tokyo, Japan
        • Tokyo Women's Medical University
      • Tokyo, Japan
        • Nippon Medical School
      • Tokyo, Japan
        • Tokai University
      • Tokyo, Japan
        • Keio University
      • Tokyo, Japan
        • Jikei University
      • Tokyo, Japan
        • NTT East Japan Kanto Medical
      • Tokyo, Japan
        • Tokyo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: desflurane
Drug: desflurane
volatile liquid for inhalation
Other Names:
  • Suprane
  • BLM-240
Experimental: desflurane/N2O
Drug: desflurane/nitrous oxide
volatile liquid for inhalation with gas for inhalation
Other Names:
  • Suprane
  • N2O
  • BLM-240
Active Comparator: sevoflurane/N2O
Drug: sevoflurane/nitrous oxide
volatile liquid for inhalation and gas for inhalation
Other Names:
  • N2O
  • sevoflurane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
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.
Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
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.
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%
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 "
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%
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
Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
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.
Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)
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).
Day 1 (Post-Surgery, from end of study drug inhalation to extubation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Awakening
Time Frame: Day 1 (Post-Surgery, from the end of study drug inhalation 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.
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)
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.
Day 1 (Post-Surgery, after extubation)
Time to Reaching an Aldrete Score >=8 (Min)
Time Frame: Day 1 (Post-Surgery, after extubation)
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.
Day 1 (Post-Surgery, after extubation)
Time to Clear Consciousness
Time Frame: Day 1 (Post-Surgery, from awakening to before extubation)
"Clear consciousness" means that patients responded to investigator's command for physical movement such as "hold my finger tight."
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)
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.
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)
Rescue medication can include vasopressors and depressors.
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)
Rescue medication can include vasopressors and depressors.
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)
Rescue medication can include vasopressors and depressors.
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]
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.
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]
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).
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]
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.
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junzo Takeda, MD, School of Medicine, Keio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLM-240-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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