Overview
Desflurane, or I-653, a a volatile anesthetic that is more rapidly cleared and less metabolized than previous inhaled anesthetics such as methoxyflurane, sevoflurane, enflurane, or isoflurane.. It was developed in the late 1980s out of a need for a more rapidly acting and rapidly cleared inhaled anesthetic. Desflurane was granted FDA approval on 18 September 1992.
Indication
Desflurane is indicated for the induction and maintenance of anesthesia in adults, as well as the maintenance of anesthesia in pediatric patients.
Associated Conditions
No associated conditions information available.
Research Report
Desflurane (DB01189): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Contemporary Role in Anesthesia
Introduction and Overview
Identity and Classification
Desflurane, identified chemically as (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether, is a highly fluorinated methyl ethyl ether that functions as a volatile liquid general anesthetic.[1] It is classified as an organofluorine compound and is administered clinically as a racemic mixture of its (R) and (S) optical isomers, or enantiomers.[1] As a member of the halogenated ether class of anesthetics, it shares a structural lineage with agents like isoflurane and sevoflurane, but possesses a unique physicochemical profile that defines its distinct clinical behavior.[2]
Historical Context and Development
Desflurane was first synthesized in the 1970s by a team led by Ross Terrell as part of a broad search for non-combustible anesthetic agents.[4] Its development was pursued in the late 1980s by Anaquest (a division of BOC Healthcare) to address a clinical demand for an inhaled anesthetic with more rapid induction and, particularly, faster emergence than the agents available at the time, such as isoflurane and halothane.[3] However, the progression of Desflurane from laboratory synthesis to clinical application was significantly delayed. This was due to formidable challenges posed by its physical properties, namely a very high vapor pressure approaching that of the atmosphere at room temperature and an associated explosive risk during its synthesis process. These hurdles postponed clinical testing until 1988.[5] Following successful trials, Desflurane was granted approval by the U.S. Food and Drug Administration (FDA) on September 18, 1992, a full decade before the widespread adoption of its main competitor, sevoflurane.[3]
Core Clinical Thesis: An Agent of Contrasts
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/14 | Not Applicable | Recruiting | Kocaeli City Hospital | ||
2025/06/11 | Not Applicable | Recruiting | |||
2025/01/17 | Phase 4 | Not yet recruiting | Georgia Tsaousi | ||
2025/01/13 | Not Applicable | Not yet recruiting | Xiaguang Duan | ||
2024/06/13 | Phase 4 | Withdrawn | Kocaeli City Hospital | ||
2024/02/09 | Not Applicable | Active, not recruiting | |||
2024/02/05 | Early Phase 1 | Not yet recruiting | Sichuan Provincial People's Hospital | ||
2023/12/19 | Not Applicable | Recruiting | |||
2023/11/09 | Not Applicable | Not yet recruiting | Ajou University School of Medicine | ||
2023/09/06 | N/A | Completed | Recep Tayyip Erdogan University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Henry Schein, Inc. | 0404-9961 | RESPIRATORY (INHALATION) | 240 mL in 240 mL | 11/16/2023 | |
General Injectables & Vaccines, Inc | 52584-641 | RESPIRATORY (INHALATION) | 240 mL in 240 mL | 12/27/2022 | |
Piramal Critical Care Inc | 66794-021 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 2/28/2023 | |
Baxter Healthcare Corporation | 10019-641 | RESPIRATORY (INHALATION) | 240 mL in 240 mL | 2/22/2023 | |
Baxter Healthcare Corporation | 10019-644 | RESPIRATORY (INHALATION) | 240 mL in 240 mL | 2/26/2015 | |
Baxter Healthcare Corporation | 10019-646 | RESPIRATORY (INHALATION) | 240 mL in 240 mL | 2/26/2015 | |
Sandoz Inc. | 0781-6172 | RESPIRATORY (INHALATION) | 240 mL in 240 mL | 11/8/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SUPRANE INHALATION ANAESTHETIC | SIN08818P | SOLUTION | 100% | 8/6/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Suprane | 162790 | Medicine | A | 6/25/2009 | |
DESFLURANE SANDOZ desflurane 1 mL/mL inhalation bottle | 286615 | Medicine | A | 3/12/2020 | |
SUPRANE desflurane 1g/g inhalation USP bottle | 60909 | Medicine | A | 8/20/1997 | |
PIRAMAL DESFLURANE desflurane 1 mL/mL inhalation bottle | 314700 | Medicine | A | 1/21/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SUPRANE | baxter corporation | 02227428 | Liquid - Inhalation | 100 % / V/V | 12/23/1996 |
DESFLURANE | blue-zone technologies ltd | 02498146 | Liquid - Inhalation | 100 % / V/V | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DESFLURANO BAXTER 100% LÍQUIDO PARA INHALACIÓN DEL VAPOR | Baxter S.L. | 88348 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Not Commercialized |
SUPRANE 100% LIQUIDO PARA INHALACION DEL VAPOR | Baxter S.L. | 60554 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Commercialized |
DESFLURANO PIRAMAL 100% LIQUIDO PARA INHALACION DEL VAPOR EFG | 80863 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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