Phase 3
Completed N=216
Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)
Anesthesia
Source: ClinicalTrials.gov NCT00762372 ↗
Enrolled (actual)
216
Serious AEs
1.8%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Body Movement During Anesthetic Maintenance — 165; 111; 54; 50 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Body Movement During Anesthetic Maintenance |
165; 111; 54; 50; 1; 0 | — |
| PRIMARY Number of Participants With Recall/Memory Issues During Anesthetic Maintenance |
165; 110; 55; 50; 0; 0 | — |
| PRIMARY Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance |
120; 75; 45; 34; 46; 36 | — |
| PRIMARY Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% |
111; 68; 43; 31; 9; 7 | — |
| PRIMARY Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70% |
46; 36; 10; 16; 0; 0 | — |
| PRIMARY Overall Assessment of Efficacy |
111; 68; 43; 31; 9; 7 | — |
| PRIMARY Time to Extubation |
9.8; 10.1; 9.3; 14.8 | — |
| SECONDARY Time to Awakening |
6.8; 7.2; 6.2; 10.4 | 0.1500 |
| SECONDARY Time to Stating Birth Date |
11.4; 11.8; 10.6; 16.2 | 0.0001 sig |
| SECONDARY Time to Reaching an Aldrete Score >=8 (Min) |
13.6; 13.9; 13.1; 18.7 | — |
| SECONDARY Time to Clear Consciousness |
7.7; 8.1; 6.9; 12.3 | — |
| SECONDARY Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance |
50.7; 48.6; 49.8; 46.3; 57.3; 48.8 | — |
| SECONDARY Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate |
6; 4; 2; 0 | 0.3113 |
| SECONDARY Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate |
40; 32; 8; 16 | — |
| SECONDARY Number of Participants Requiring Rescue Medication Due to Arrhythmia |
3; 1; 2; 0 | 1.0000 |
| SECONDARY Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance |
3; 4; 1.2; 4; 5; 1.4 | — |
| SECONDARY Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance |
0.3; 0.1; 0.5; 0.3 | — |
| SECONDARY End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia |
3.97; 3.69; 4.48; 1.30 | — |
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
Data sourced from ClinicalTrials.gov (NCT00762372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.