AHFS Class:

• Non-barbiturates 28:04.08

Generic Name(s):

• Etomidate

Etomidate is a sedative and hypnotic agent used for general anesthesia.1,2,3,4,5,756,765

Induction and Maintenance of Anesthesia

Etomidate is used IV for induction of general anesthesia.1,2,3,4,5 Etomidate may be particularly useful in patients with compromised cardiopulmonary function because of its minimal hemodynamic effects and decreased respiratory depressant effects relative to other IV anesthetics (e.g., barbiturates, propofol). However, the manufacturers state that the potential benefits of the drug's hemodynamic effects must be weighed carefully against the possible risk of involuntary skeletal muscle movements (e.g., myoclonus).1,2,774 (See Cautions: Common Adverse Effects.)

Etomidate also is used during maintenance of anesthesia to supplement subpotent anesthetic agents (e.g., nitrous oxide and oxygen) during short surgical procedures (e.g., dilatation and curettage, cervical conization).1,2 Use of the drug for longer procedures is not recommended due to an increased risk of prolonged adrenal suppression.1,2 (See Adrenal Suppression under Cautions: Warnings/Precautions.)

When used for induction of anesthesia, etomidate is administered IV by rapid (over 30-60 seconds) injection.1,2 Induction with IV etomidate is rapid and results in dose-related hypnotic effects (progressing from light sleep to unconsciousness); the drug also has some amnestic effects, but lacks analgesic properties.1,2,3,4,5,6,9,765 Following administration of a standard induction dose of 0.3 mg/kg, hypnosis occurs in less than 1 minute and is maintained for about 3-10 minutes.1,765,768

For further information on induction and maintenance of anesthesia, see Uses: Induction and Maintenance of Anesthesia, in Propofol 28:04.92.

Rapid Sequence Intubation

Because of its rapid onset and favorable hemodynamic profile, etomidate is commonly used (and often the preferred induction agent) for rapid sequence intubation.12,754,755,761,765,767,768,772,773 Rapid sequence intubation involves the administration of a potent sedative (induction agent) and a neuromuscular blocking agent virtually simultaneously to facilitate rapid tracheal intubation.764 However, the potential for etomidate to cause adrenal suppression may limit its use in critically ill patients (particularly those with sepsis).12,766,767,769,774 (See Adrenal Suppression under Cautions: Warnings/Precautions.)

Procedural Sedation

Etomidate has been used for procedural sedation† in the emergency department and other outpatient settings (e.g., clinic).756,757,758,759,760,763,821,822,823 Because of its relatively short duration of action, the drug is best suited for procedures of short duration.756,759 Etomidate does not exhibit analgesic properties and generally is used concomitantly with an opiate agonist (e.g., fentanyl).756,759

Procedural sedation is a technique in which sedative or dissociative agents are administered with or without analgesics to allow patients to tolerate painful or unpleasant medical procedures; a depressed state of consciousness is intentionally induced while cardiorespiratory function is maintained.821,822,823 Because sedation is a continuum ranging from minimal sedation to general anesthesia, airway reflexes and cardiorespiratory function may be impaired if a deeper than intended level of sedation is produced.821,822,823 The appropriate level of sedation should be individualized according to the specific procedure and needs of the patient.822

In clinical studies conducted in both adults and pediatric patients, etomidate (in doses less than those used for anesthesia) produced adequate sedation and facilitated the successful completion of a short painful procedure (e.g., fracture reduction, laceration repair, shoulder relocation).756,757,758,759,761,762,763,821,823 Time to onset of sedation and recovery with etomidate are comparable to those achieved with propofol, but considerably shorter than with midazolam.758,760,761,762,763,822 Adverse effects that occur more frequently with etomidate than with other sedative agents include myoclonus and pain at the injection site.758,760,761,821 Although respiratory depression or apnea also has been reported to occur in some patients receiving etomidate, the incidence is generally the same or less than that with other sedative agents.756,760,761,763,765

General

Etomidate should be administered only by clinicians experienced in the use of general anesthetic drugs and in the management of possible complications associated with their use (e.g., airway or respiratory compromise).1,2,764,770,771,823

Common premedications such as benzodiazepines (to relieve anxiety and produce anterograde amnesia) and opiate agonists (to relieve pain) may be administered as appropriate.1,2,9,10

Administration

Etomidate is administered by IV injection over 30-60 seconds.1,2 The drug should be injected undiluted by direct IV injection.10 Some clinicians state that etomidate may be administered by intraosseous (IO) injection† in the setting of pediatric rapid sequence intubation.13 Although the drug has been administered as a continuous IV infusion†, this method of delivery is currently not recommended because of the risk of adrenal toxicity.1,2,6,765 (See Adrenal Suppression under Cautions: Warnings/Precautions.)

Etomidate injection should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.1,2 The injection should not be administered unless the solution is clear and the container is undamaged; unused portions should be discarded.1,2

Limited data from clinical and animal studies indicate that inadvertent intra-arterial administration of etomidate injection does not appear to be associated with tissue necrosis distant from the injection site; however, intra-arterial use of the drug is not recommended.1,2,9 Pain at the injection site, which occurs frequently and usually is mild to moderate in severity (although occasionally may be severe), can be minimized if the larger, more proximal veins of the forearm, rather than the smaller, distal hand or wrist veins are used.1,2,3,9 To prevent needlestick injuries, needles should not be recapped, bent, or broken by hand.1

Etomidate injection is compatible with commonly used premedicants administered prior to induction of anesthesia.1,2,9

Dosage

Dosage of etomidate should be adjusted according to individual requirements and response, age, physical and clinical status, underlying pathologic conditions (e.g., shock, intestinal obstruction, malnutrition, anemia, burns, advanced malignancy, ulcerative colitis, uremia, alcoholism), and the type and amount of premedication or concomitant medication(s).1,2,9 In addition, dosage of the drug should be titrated to clinical effect.9

Induction and Maintenance of Anesthesia

The usual dose of etomidate for induction of anesthesia in adults and children older than 10 years of age is 0.3 mg/kg (0.2-0.6 mg/kg), administered by IV injection over 30-60 seconds.1,2,9

When etomidate is used during maintenance of anesthesia to supplement subpotent anesthetic agents during short surgical procedures, smaller increments of etomidate may be administered.1,2

Rapid Sequence Intubation

For rapid sequence intubation, etomidate is usually administered in a dose of 0.3 mg/kg IV.754,755,768 The manufacturers state that there are inadequate data to make dosage recommendations for pediatric patients younger than 10 years of a 1,2 however, in published reports, etomidate was used in pediatric patients as young as 18 days of age at an average dose of 0.3 mg/kg.772,773 Some clinicians recommend an etomidate dose of 0.3 mg/kg by IV or IO† injection for pediatric rapid sequence intubation.13

Procedural Sedation

Doses of etomidate used for procedural sedation† are usually less than those used for induction of anesthesia; in clinical studies, an initial IV etomidate dose of 0.1-0.2 mg/kg was usually administered, followed by additional doses of 0.05-0.1 mg/kg given as needed for adequate sedation (average total dose of up to 0.26 mg/kg per procedure) in adults and pediatric patients.756,758,759,760,761,762,763 Some studies have found that a dose of 0.2 mg/kg was the most effective initial dose for short pediatric procedures in the emergency department.756

Special Populations

Since clinical studies have revealed pharmacokinetic differences (decreased initial distribution volumes and total clearance, decreased serum protein binding to albumin) between geriatric and younger patients, geriatric patients may require lower dosages of etomidate than younger patients.2,765

Contraindications

Known hypersensitivity to etomidate.1,2

Warnings/Precautions

Administration Precautions

To minimize the risk of adverse effects, recommendations for administration and monitoring of etomidate therapy should be followed.1 (See Dosage and Administration.)

Adrenal Suppression

Etomidate is known to cause adrenal suppression by inhibiting 11-β-hydroxylase activity, the enzyme responsible for production of cortisol and aldosterone.1,765,766,768 Decreased plasma concentrations of cortisol, which usually persist for 6-8 hours and are unresponsive to stimulation by corticotropin (ACTH), have been reported following IV administration of a single induction dose of etomidate (0.3 mg/kg).1,2,3,4,5,6,768 Because of the risk of prolonged suppression of endogenous cortisol and aldosterone secretion from the adrenal cortex, administration of etomidate as a continuous IV infusion is not recommended.1,2,6

Although it is well established that etomidate can cause adrenal suppression, there is controversy regarding the clinical importance of this observed effect.12,766,767,768 Some evidence from a randomized controlled study suggested a possible link between the use of etomidate and increased mortality in critically ill patients (particularly those with sepsis); however, other studies have not found such an association.766,767,768,769,774 Studies comparing etomidate to other induction agents (e.g., midazolam, ketamine) for endotracheal intubation have not shown any strong evidence that etomidate increases mortality when compared with these other agents.767,768

Specific Populations

Pregnancy

There are no adequate and well controlled studies of etomidate in pregnant women; in animal reproduction studies, reduced pup survival and maternal toxicity have been observed.1

Based on animal data, repeated or prolonged use of general anesthetics and sedation drugs, including etomidate, during the third trimester of pregnancy may result in adverse neurodevelopmental effects in the fetus.750,753 The clinical relevance of these animal findings to humans is not known; the potential risk of adverse neurodevelopmental effects should be considered and discussed with pregnant women undergoing procedures requiring general anesthetics and sedation drugs.750 (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

There are insufficient data to support the use of etomidate during labor and delivery; use is therefore not recommended in the obstetric setting, including in patients undergoing cesarean section.1,2

Lactation

It is not known whether etomidate is distributed into milk in humans.1,2 Because many drugs are distributed into human milk, caution is advised if etomidate is used in nursing women.1,2

Pediatric Use

The manufacturers state that safety and efficacy of etomidate for induction or maintenance of anesthesia have not been established in children younger than 10 years of age.1,2,10 However, the drug has been used for rapid sequence intubation in pediatric patients as young as 18 days of age.772,773 Etomidate also has been used in children of all ages for procedural sedation† in the emergency department.756,757,758,759,762

FDA warns that repeated or prolonged use of general anesthetics and sedation drugs, including etomidate, in children younger than 3 years of age or during the third trimester of pregnancy may affect brain development.750,753 Animal studies in multiple species, including nonhuman primates, have demonstrated that use for longer than 3 hours of anesthetic and sedation drugs that block N -methyl-d-aspartic acid (NMDA) receptors and/or potentiate γ-aminobutyric acid (GABA) activity leads to widespread neuronal and oligodendrocyte cell loss and alterations in synaptic morphology and neurogenesis in the brain, resulting in long-term deficits in cognition and behavior.750,751,752,753 Across animal species, vulnerability to these neurodevelopmental changes occurs during the period of rapid brain growth or synaptogenesis; this period is thought to correlate with the third trimester of pregnancy through the first year of life in humans, but may extend to approximately 3 years of age.750 The clinical relevance of these animal findings to humans is not known.750

While some published evidence suggests that similar deficits in cognition and behavior may occur in children following repeated or prolonged exposure to anesthesia early in life, other studies have found no association between pediatric anesthesia exposure and long-term adverse neurodevelopmental outcomes.750,752 Most studies to date have had substantial limitations, and it is not clear whether the adverse neurodevelopmental outcomes observed in children were related to the drug or to other factors (e.g., surgery, underlying illness).750 There is some clinical evidence that a single, relatively brief exposure to general anesthesia in generally healthy children is unlikely to cause clinically detectable deficits in global cognitive function or serious behavioral disorders;750,751,752 however, further research is needed to fully characterize the effects of exposure to general anesthetics in early life, particularly for prolonged or repeated exposures and in more vulnerable populations (e.g., less healthy children).750 For further information, see Cautions: Pediatric Precautions, in Propofol 28:04.92.

Anesthetic and sedation drugs are an essential component of care for children and pregnant women who require surgery or other procedures that cannot be delayed;750,753 no specific general anesthetic or sedation drug has been shown to be less likely to cause neurocognitive deficits than any other such drug.750 Pending further accumulation of data in humans from well-designed studies, decisions regarding the timing of elective procedures requiring anesthesia should take into consideration both the benefits of the procedure and the potential risks.750 When procedures requiring the use of general anesthetics or sedation drugs are considered for young children or pregnant women, clinicians should discuss with the patient, parent, or caregiver the benefits, risks (including potential risk of adverse neurodevelopmental effects), and appropriate timing and duration of the procedure.750,753 FDA states that procedures that are considered medically necessary should not be delayed or avoided.750,753

Geriatric Use

Clinical data indicate that etomidate may be associated with cardiac depression (decreased heart rate and cardiac index) and decreased mean arterial blood pressure in geriatric patients, especially those with hypertension.2 Etomidate is substantially excreted by the kidneys and the risk of severe adverse reactions to the drug may be increased in patients with impaired renal function.2 Because geriatric patients may have decreased renal function, it may be useful to monitor renal function, and dosage should be selected with caution in such patients.2 (See Dosage and Administration: Special Populations.)

Hepatic Impairment

Etomidate is metabolized by the liver; patients with hepatic insufficiency may be at higher risk of adverse effects (e.g., adrenal insufficiency).774 In patients with cirrhosis, elimination half-life of etomidate is approximately double that seen in healthy individuals.1

Renal Impairment

Because etomidate is substantially excreted renally, the risk of serious adverse effects is increased in patients with renal impairment.1

Common Adverse Effects

The most frequent adverse effects associated with IV use of etomidate are transient venous pain at the injection site and transient skeletal muscle movements (i.e., myoclonus), which occur in about 20% (range: 1-42%) and 32% (range: 23-63%) of patients, respectively.1,2,3,4,9,758,760,761,821 Although generally mild to moderate in severity, such adverse effects can occasionally be severe.1,2,761

Most (74%) cases of transient skeletal muscle movements have been classified as myoclonic, but tonic movements (10%), ocular movements (9%), and averting movements (7%) also have been noted.1,2 Such movements are usually bilateral (of the arms, legs, shoulders, neck, chest wall, trunk, and/or all 4 extremities, with one or more muscle groups predominating), with an electroencephalogram (EEG) suggesting that they are manifestations of cortical disinhibition in the absence of evidence of seizure activity.1,2 Alternatively, muscle movements may be unilateral or predominate on one side (e.g., predominance of movement of the arm in which the IV was started), or a mixture of bilateral and unilateral types may occur.1,2 The incidence of skeletal muscle movements, particularly those considered disturbing, has been minimized with IV10 administration of fentanyl immediately before induction of anesthesia with etomidate.1,2

Other adverse effects reported in patients receiving etomidate include hyperventilation, hypoventilation, apnea (duration: 5-90 seconds), laryngospasm, hiccups and snoring (may be associated with partial upper airway obstruction), hypertension, hypotension, arrhythmias (e.g., tachycardia, bradycardia), and postoperative nausea and vomiting.1,2,4

Neuromuscular Blocking Agents

Etomidate does not appear to alter usual dosage requirements of neuromuscular blocking agents used for endotracheal intubation or any other purpose.1,2

Opiate Agonists

Because of a potential additive pharmacologic effect when etomidate is used with an opiate agonist (e.g., fentanyl), dosage adjustments (i.e., decrease in etomidate dosage) may be necessary.1,2,10

Description

Etomidate, a carboxylated imidazole, is a sedative and hypnotic agent used for general anesthesia.1,2,3,4,5 The drug is structurally unrelated to other currently available IV anesthetics.6

Following IV injection, etomidate has a rapid onset of action1,2,3,4,5,6 and will produce loss of consciousness within 1 arm-brain circulation time (i.e., usually within about 60 seconds).4,9 Etomidate produces its anesthetic activity by enhancing the activity of γ-aminobutyric acid (GABA), the principal inhibitory neurotransmitter in the CNS,6,7 through modulation and direct activation of the GABA_A receptor complex.6,7,765

Etomidate is capable of producing all levels of CNS depression—from light sleep to deep coma—depending on the dosa 9 however, the drug has no analgesic activity.1,2,4 The degree of depression and duration of action depend on dosage, rate and route of administration, and pharmacokinetics of the drug.9 Substantial changes on the EEG appear to occur following induction doses of etomidate.3,4,9 The EEG changes are indicative of the various stages of anesthesia and appear to be similar to those occurring following induction of anesthesia with barbiturates.3,4 Etomidate may decrease cerebral blood flow and intracranial pressure, while cerebral perfusion pressure is increased or maintained during induction of anesthesia.1,3,9,765

Etomidate causes minimal hemodynamic changes9 and is associated with a decreased incidence and severity of cardiovascular effects compared with other IV anesthetic agents.3,4,5,6,10 Minor increases in cardiac index and slight decreases in heart rate, systemic vascular resistance, and arterial blood pressure have been reported with use of etomidate.9 In addition, equivalent induction doses of etomidate cause less respiratory depression than propofol or barbiturates.9 Increases in carbon dioxide tension (PCO₂) have been reported with administration of etomidate.1,2

Some data suggest that etomidate usually reduces intraocular pressure (IOP).1,2

The pharmacokinetic profile of etomidate is characterized by a rapid distribution from blood into CNS, rapid clearance from the brain, and substantial tissue uptake.3,4 Following the usual induction dose (0.3 mg/kg) of etomidate, duration of hypnosis is short (about 3-10 minutes) and dose dependent.1,2,765,768 The elimination half-life of etomidate is about 1.25-5 hours.1,2,3,4,8 The drug is rapidly metabolized in the liver, principally by hydrolysis, to form etomidate carboxylic acid,1,2,3,4,8 which appears to be pharmacologically inactive.4 About 75% of an administered dose is excreted in urine within 24 hours, mainly (about 80%) as the carboxylic acid metabolite,1,2,4 while 13 and 10% of a dose are excreted in feces and bile, respectively.4

Advice to Patients

When procedures requiring general anesthetics or sedation drugs, including etomidate, are considered for young children or pregnant women, importance of discussing with the patient, parent, or caregiver the benefits, risks (including potential risk of adverse neurodevelopmental effects), and appropriate timing and duration of the procedure.750,753

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1,2

Importance of women informing clinicians if they are or plan to become pregnant or are breast-feeding.1

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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