Overview
Sevoflurane is an ether inhalation anesthetic agent used to induce and maintain general anesthesia. It is a volatile, non-flammable compound with a low solubility profile and blood/gas partition coefficient. Sevoflurane was patented in 1972, was approved for clinical use in Japan in 1990, and approved by the FDA in 1996. Sevoflurane is three times more potent than desflurane, but has lower potency compared to halothane and isoflurane. Unlike other volatile anesthetics, sevoflurane has a pleasant odor and does not irritate the airway. The hemodynamic and respiratory depressive effects of sevoflurane are well tolerated, and most patients receiving this anesthetic agent present little toxicity. Therefore, it can be used for inhalational induction in adults and children for a wide variety of anesthetic procedures.
Indication
Sevoflurane is used for the induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
Associated Conditions
No associated conditions information available.
Research Report
Sevoflurane (DB01236): A Comprehensive Pharmacological Review
1. Introduction
1.1. Overview of Sevoflurane as an Inhalational Anesthetic Agent
Sevoflurane is a highly fluorinated methyl isopropyl ether, widely utilized as a volatile inhalational anesthetic for the induction and maintenance of general anesthesia across diverse patient populations, including adults and pediatrics, for both inpatient and outpatient surgical interventions.[1] Its clinical utility is largely attributed to a favorable combination of properties: a rapid, smooth onset of action and quick emergence from anesthesia, a non-pungent, pleasant odor which facilitates mask induction (particularly advantageous in pediatric patients), and a general lack of irritation to the respiratory tract.[1] These characteristics, alongside a generally well-tolerated safety profile and predictable pharmacokinetics, have positioned sevoflurane as a cornerstone agent in contemporary anesthetic practice.[1]
The landscape of inhalational anesthesia has seen a progressive shift, with agents like sevoflurane, often alongside desflurane, increasingly supplanting older volatile anesthetics such as isoflurane and halothane in modern clinical settings.[11] Sevoflurane's global adoption since its introduction reflects its perceived advantages in clinical practice.[1] This evolution is driven by a pursuit of anesthetic agents that offer enhanced control, improved patient experience, and more favorable recovery profiles. Older agents, while effective, presented certain limitations; for instance, isoflurane has a slower onset and offset, and halothane carried concerns regarding arrhythmogenicity and hepatotoxicity. Sevoflurane's low blood:gas solubility coefficient is a primary determinant of its rapid induction and emergence characteristics, a significant improvement for both procedural efficiency and patient recovery post-anesthesia.[1] Furthermore, its non-pungent, sweet odor makes it particularly
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/29 | Not Applicable | Active, not recruiting | |||
2025/07/14 | Not Applicable | Recruiting | |||
2025/06/25 | Not Applicable | Not yet recruiting | Second Affiliated Hospital of Wenzhou Medical University | ||
2025/06/24 | Not Applicable | Completed | Ataturk Training and Research Hospital | ||
2025/06/11 | Not Applicable | Recruiting | |||
2025/04/20 | N/A | Completed | |||
2025/04/02 | Not Applicable | Not yet recruiting | |||
2025/02/19 | Not Applicable | Completed | |||
2025/02/18 | Not Applicable | Recruiting | Kocaeli City Hospital | ||
2025/01/17 | Phase 4 | Not yet recruiting | Georgia Tsaousi |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Bryant Ranch Prepack | 72162-2245 | RESPIRATORY (INHALATION) | 1 mL in 1 mL | 1/29/2024 | |
Baxter Healthcare Company | 10019-655 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 5/31/2023 | |
Baxter Healthcare Corporation | 10019-655 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 5/31/2023 | |
Piramal Critical Care Inc | 66794-022 | RESPIRATORY (INHALATION) | 1 mL in 1 mL | 1/24/2024 | |
Lannett Company, Inc. | 0527-6123 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 9/19/2023 | |
AbbVie Inc. | 0074-4456 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 8/30/2022 | |
Piramal Critical Care Inc | 66794-015 | RESPIRATORY (INHALATION) | 1 mL in 1 mL | 8/11/2025 | |
AbbVie Inc. | 0074-4456 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 9/8/2022 | |
Baxter Healthcare Corporation | 10019-657 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 5/31/2023 | |
Baxter Healthcare Corporation | 10019-653 | RESPIRATORY (INHALATION) | 250 mL in 250 mL | 5/31/2023 |
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 |
---|---|---|---|---|---|
Sevoflurane Inhalation Anaesthetic Liquid 100% | SIN13741P | INHALANT | 1ml/ml | 11/26/2009 | |
SEVORANE INHALATION | SIN08264P | SOLUTION | 100% | 7/25/1995 | |
SOJOURN INHALATION ANAESTHETIC LIQUID 100% | SIN14780P | INHALANT | 100% v/v | 5/8/2015 | |
NOREVELL INHALATION ANAESTHETIC LIQUID 100% | SIN16819P | INHALANT | 100% | 7/10/2023 |
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 |
---|---|---|---|---|---|
PIRAMAL SEVOFLURANE Sevoflurane liquid for inhalation 100% v/v bottle | 202776 | Medicine | A | 2/28/2014 | |
BAXTER SEVOFLURANE sevoflurane 250mL inhalation liquid bottle | 106647 | Medicine | A | 8/3/2004 | |
SEVOFLURANE SANDOZ sevoflurane 1 mL/mL inhalation bottle | 286635 | Medicine | A | 3/12/2020 | |
Sevoflurane 100% | 260454 | Medicine | A | 9/30/2015 | |
SEVORANE sevoflurane anaesthetic inhalation bottle | 51919 | Medicine | A | 1/4/1996 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SEVOFLURANE | baxter corporation | 02265974 | Liquid - Inhalation | 99.97 % | 4/11/2007 |
SEVOFLURANE | blue-zone technologies ltd | 02553449 | Liquid - Inhalation | 99.9875 % / V/V | N/A |
SEVORANE AF | 02172763 | Liquid - Inhalation | 99.97 % | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
SEVOFLURANO PIRAMAL 100% LIQUIDO PARA INHALACION DEL VAPOR EFG | 74985 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Commercialized | |
SEVOFLURANO BAXTER 100% LIQUIDO PARA INHALACION DEL VAPOR EFG | Baxter S.L. | 72200 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Commercialized |
SEVOFLURANO ELC 100% LIQUIDO PARA INHALACION DEL VAPOR EFG | Elc Group S.R.O. | 89594 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Not Commercialized |
SEVOFLURANO CADIASUN 100% LIQUIDO PARA INHALACION DEL VAPOR EFG | Cadiasun Pharma Gmbh | 79600 | LÍQUIDO PARA INHALACIÓN DEL VAPOR | Uso Hospitalario | Not Commercialized |
SEVORANE 100% LIQUIDO PARA INHALACION DEL VAPOR | Abbvie Spain, S.L.U. | 61451 | 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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