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

NCT00762372 | Completed Phase 2 Results

• 1 other identifier: BLM-240-003
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 15

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.

Conditions

Anesthesia

Keywords

anesthesia; desflurane

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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 "

  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

  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.

  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).

  Day 1 (Post-Surgery, from end of study drug inhalation to extubation)

Secondary Outcomes (11)

• Time to Awakening

  Day 1 (Post-Surgery, from the end of study drug inhalation to awakening)

• Time to Stating Birth Date

  Day 1 (Post-Surgery, after extubation)

• Time to Reaching an Aldrete Score >=8 (Min)

  Day 1 (Post-Surgery, after extubation)

• Time to Clear Consciousness

  Day 1 (Post-Surgery, from awakening to before extubation)

• Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance

  Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)

Study Arms (3)

desflurane

EXPERIMENTAL

Drug: desflurane

desflurane/N2O

EXPERIMENTAL

Drug: desflurane/nitrous oxide

sevoflurane/N2O

ACTIVE COMPARATOR

Drug: sevoflurane/nitrous oxide

Interventions

desflurane DRUG

volatile liquid for inhalation

Also known as: Suprane, BLM-240

desflurane

desflurane/nitrous oxide DRUG

volatile liquid for inhalation with gas for inhalation

Also known as: Suprane, BLM-240, N2O

desflurane/N2O

sevoflurane/nitrous oxide DRUG

volatile liquid for inhalation and gas for inhalation

Also known as: sevoflurane, N2O

sevoflurane/N2O

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (15)

Kagoshima University Medical and Dental University

Kagoshima, Japan

Location

Kyoto University

Kyoto, Japan

Location

Nagoya University

Nagoya, Japan

Location

Okayama University

Okayama, Japan

Location

Osaka University

Osaka, Japan

Location

Sapporo Medical University

Sapporo, Japan

Location

Hamamatsu University

Shizuoka, Japan

Location

Jikei University

Tokyo, Japan

Location

Juntendo University

Tokyo, Japan

Location

Keio University

Tokyo, Japan

Location

Nippon Medical School

Tokyo, Japan

Location

NTT East Japan Kanto Medical

Tokyo, Japan

Location

Tokai University

Tokyo, Japan

Location

Tokyo University

Tokyo, Japan

Location

Tokyo Women's Medical University

Tokyo, Japan

Location

MeSH Terms

Interventions

Desflurane; Nitrous Oxide; Sevoflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Baxter Clinical Trial Disclosures Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224)948-7359

Study Officials

• Junzo Takeda, MD

  School of Medicine, Keio University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2018-11

Locations

JP (15)