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desflurane

Phase 4FDA approved

Cystoscopes | Small molecule | Other |Baxter International Inc.|Trials Updated: Nov 16, 2021

desflurane development status

FDA approval on record Dec 15, 2006 as Suprane
Approval holderBaxter Hlthcare
ApplicationNDA020118
Highest phase Phase 4 (NCT02019797)
Phase scored for BAXPhase 3
Registered trials 12 across 12 sponsors since Sep 2008

Label indication SUPRANE, a general anesthetic, is an inhalation agent indicated: • for induction and/or maintenance of anesthesia in adults ( 1.1 ) • for maintenance of anesthesia in pediatric patients following induction with agents other than SUPRANE and intubation. 1.1 Induction of Anesthesia SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. FDA label

desflurane target and mechanism

Molecular targetKCNK10, KCNK18, KCNK2, KCNK9, GABRA1, GABRB2
Target classOpener
ModalitySmall molecule

Also known as Suprane, BLM-240

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment291

FDA Designations

No designations recorded

desflurane clinical trials

desflurane · 2 trials · 4 indications

Phase 3 1Phase 2 1
NCT01219881Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope SurgeryCystoscopes
COMPLETED75 Analytics
PHASE3COMPLETED
Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery
CystoscopesUnlock trial analytics

Study Endpoints

Primary Endpoints

Recovery Time
14 Days

Recovery Time after exposure to desflurane or sevoflurane considering time of emergence from anesthesia

Number of Participants With Body Movement During Anesthetic Maintenance
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
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
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%
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%
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
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
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).

Secondary Endpoints

Difference in Time to Orientation
14 Days
Time to Extubation
14 days
Incidence of Coughing at Extubation, Approximately 10 Minutes After End of Surgery
At extubation, approximately 10 minutes after end of surgery
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
DesfluraneACTIVE_COMPARATORComparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.
SevofluraneACTIVE_COMPARATORComparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.
desflurane/N2OEXPERIMENTAL -
sevoflurane/N2OACTIVE_COMPARATOR -

Interventions

NameTypeDescription
DesfluraneDRUG5.4 to 7.4% desflurane
SevofluraneDRUG1.4 to 2.5% Sevoflurane
desflurane/nitrous oxideDRUGvolatile liquid for inhalation with gas for inhalation
sevoflurane/nitrous oxideDRUGvolatile liquid for inhalation and gas for inhalation
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Eligibility Criteria

Age Range50 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United StatesJapan
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Frequently asked questions about desflurane

What is desflurane used for?

Desflurane is an inhaled anesthetic agent used to induce and maintain general anesthesia during surgical procedures. Its studied uses include anesthesia in adult patients and anesthesia for urological cystoscope surgery. It is a small molecule drug developed by Baxter International Inc. under the ticker BAX.

What does desflurane target?

Desflurane targets potassium channel subunits KCNK10, KCNK18, KCNK2, and KCNK9, as well as the GABA-A receptor subunits GABRA1 and GABRB2. It acts as a channel opener. Activity at these two-pore-domain potassium channels and GABA-A receptors is the basis of its anesthetic mechanism.

Who makes desflurane?

Desflurane is developed by Baxter International Inc., which trades under the ticker BAX. Baxter is associated with the Baxter Anaesthesia brand of desflurane studied in clinical research. The drug is a small molecule anesthetic agent in the pain therapeutic area.

What phase is desflurane in?

Desflurane has been studied in Phase 2 and Phase 3 clinical trials. It is an investigational asset in the development pipeline tracked for Baxter International Inc. Its registered studies are completed, with no active trials currently listed.

What clinical trials is desflurane in?

Desflurane has been evaluated in two completed trials. NCT01219881 compared desflurane to sevoflurane for recovery time in patients undergoing urological cystoscope surgery in the United States. NCT00762372 was a Japan Phase 2/3 study of BLM-240 (desflurane) in anesthesia, enrolling 216 patients.

Is desflurane the same as BLM-240?

Yes, BLM-240 is an alternative name for desflurane. The Japan Phase 2/3 clinical study NCT00762372 was conducted with BLM-240 (desflurane) in patients receiving anesthesia. Readers searching for BLM-240 are looking at the same active agent as desflurane.