Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Desflurane · 2 trials · 4 indications
Recovery Time after exposure to desflurane or sevoflurane considering time of emergence from anesthesia
The investigator or sub-investigator observed the patient for body movement (excluding bucking) 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.
Rescue medication includes vasopressors and depressors.
"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 "
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
Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.
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).
| Arm | Type | Description |
|---|---|---|
| Desflurane | ACTIVE_COMPARATOR | Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane. |
| Sevoflurane | ACTIVE_COMPARATOR | Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane. |
| desflurane/N2O | EXPERIMENTAL | - |
| sevoflurane/N2O | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Desflurane | DRUG | 5.4 to 7.4% desflurane |
| Sevoflurane | DRUG | 1.4 to 2.5% Sevoflurane |
| desflurane/nitrous oxide | DRUG | volatile liquid for inhalation with gas for inhalation |
| sevoflurane/nitrous oxide | DRUG | volatile liquid for inhalation and gas for inhalation |
Inclusion Criteria: 1. Male or female, 50 to 75 years of age. 2. Subjects with an American Society of Anesthesiologist (ASA) physical status of I to III. 3. Subjects able to provide written informed consent to participate in the study. 4. Female subjects who have a negative urine or serum pregnancy...
Desflurane is an inhaled anesthetic used to maintain general anesthesia during surgical procedures. It is being studied for use in urological cystoscope surgery, where it is compared to sevoflurane for its effect on recovery time. Desflurane is also investigated for anesthesia in broader clinical settings.
Desflurane is developed by Baxter International Inc., a company publicly traded under the ticker symbol BAX. Baxter is conducting clinical trials to evaluate the drug's safety and efficacy in anesthesia and cystoscope procedures.
Desflurane is in Phase 3 clinical development. One completed Phase 3 trial compared desflurane to sevoflurane in patients undergoing urological cystoscope surgery. The drug remains investigational and is not yet approved for these specific uses.
Desflurane has been studied in two completed clinical trials. NCT00762372 was a Phase 2/3 study in Japan with 216 patients evaluating the drug for anesthesia. NCT01219881 was a Phase 3 trial in the United States with 75 patients comparing desflurane to sevoflurane for recovery time in cystoscope surgery.
Desflurane is a small molecule anesthetic that works by depressing the central nervous system to produce a state of general anesthesia. It is administered by inhalation and acts to induce and maintain unconsciousness during surgical procedures, allowing patients to undergo operations without awareness or pain.
Desflurane is an investigational drug in clinical development and has not been approved by the FDA for the indications studied. It has completed Phase 2 and Phase 3 trials, but no approval status has been established. The drug remains under evaluation for anesthesia and cystoscope procedures.