ETOMIDATE
Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ).
Details
- Status
- Discontinued
- First Approved
- 1996-11-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ETOMIDATE Approval History
What ETOMIDATE Treats
11 FDA approvalsOriginally approved for its first indication in 1996 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Nov 1996)
- • Approved indication (Jan 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2012)
- • Approved indication (Jul 2014)
- • Approved indication (Aug 2014)
- • Approved indication (Feb 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Feb 2017)
- • Approved indication (Apr 2017)Letter
- • Approved indication (Dec 2020)
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05277896 RSI results posted | 210500 K23HL153584, BPS-2022C3-30021 | Ph 4 | completed | Randomized Trial of Sedative Choice for Intubation |
| NCT06664138 | DKUH 2023-02-005-002 | Ph 4 | completed | Comparison of Remimazolam and Etomidate As Induction Agents for Electroconvulsive Treatment |
| NCT05223907 | ytmz | Ph 4 | completed | Safety and Efficacy of Maintenance of Etomidate in General Anesthesia |
| NCT06068764 ETOPRO | HHC-2023-0114 | Ph 4 | recruiting | Etomidate Versus Propofol in CABG Surgery |
| NCT02822144 GASS | 35RC15_8957 2016-000795-25 | Ph 3 | completed | General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke |
| NCT02643381 EvK results posted | 022015-023 | Ph 4 | completed | Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial |
| NCT03545503 Ket-RSI results posted | 1712-4 | Ph 4 | completed | Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation |
| NCT02105415 KEEP PACE results posted | 13-000506 | Ph 2, Ph 3 | completed | Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial |
| NCT01823328 results posted | HSR 13-3601 | Ph 4 | completed | Ketamine Versus Etomidate for Rapid Sequence Intubation |
| NCT02500225 | Ulku 1 | Ph 4 | completed | Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy |
| NCT02027311 results posted | ETOMI-1 | Ph 4 | completed | Etomidate vs. Midazolam for Sedation During ERCP |
| NCT02186990 | Odu-2 | Ph 4 | completed | Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation |
| NCT01495949 | Si559/2011 | Ph 4 | completed | The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone |
| NCT01792037 | 26177 | Ph 4 | completed | Single Dose of Etomidate and Adrenal Cortex |
| NCT01248234 | 2010-0097 | Ph 3 | withdrawn | Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone? |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ETOMIDATE FDA Label Details
Indications & Usage
Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous Etomidate Injection is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
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AMIDATE
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.