Ketamine  is a nonbarbiturate rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeal – laryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation and occasionally a transient and minimal respiratory depression.

 

KETAMINE ELSaad is indicated:

- As the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.

- For short procedures but it can be used, with additional doses, for longer procedures.

- For the induction of anesthesia prior to the administration of other general anesthetic agents.

- To supplement low-potency agents such as nitrous oxide.

 

Ketamine HCl is contraindicated in-patients in whom a significant elevation in blood pressure would constitute a serious hazard, and in those who have shown hypersensitivity to the drug.

 

Cardiac function should be continually monitored during the procedure in-patients found to have hypertension or cardiac decompensation.

Postoperative confusional states may occur during the recovery period. The incidence of this effect is least in the young (15 years of age or less) and elderly (over 65 years of age) patient. Also it is less frequent when the drug is given intramuscularly. The incidence of psychological manifestations during emergence, particularly, dream-like observation and delirium, may be reduced by using lower recommend dosages of Ketamine in conjunction with intravenous Diazepam during induction and maintenance of anesthesia. In order to terminate a severe emergence reaction the use of small hypnotic dose of a short-acting or ultrashort-acting barbiturate may be required.

 

An increase in cerebrospinal fluid pressure has been reported following administration of Ketamine. Use with extreme caution in-patients with preanesthetic elevated cerebrospinal fluid pressure. It also may cause a slight elevation in intraocular pressure measurement.

When Ketamine is used on an outpatient basis, the patient should not be released until recovery from anesthesia is complete and then should be accompanied by a responsible adult. Because pharyngeal and laryngeal reflexes are usually active, Ketamine should not be used alone in surgery or diagnostic procedures of the pharynx, larynx or bronchial tree. Mechanical stimulation of the pharynx should be avoided whenever possible if Ketamine is used alone. Muscle relaxants, with proper attention to respiration, may be required in both of these instances. In surgical procedures involving visceral pain pathways, Ketamine should be supplemented with an agent which obtunds visceral pain. Ketamine must not be used with Ergometrine.

 

Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Ketamine  alone. This elevation of blood pressure may be considered an adverse reaction or a beneficial effect. However, hypotension, bradycardia and arrhythmia have been reported.

Respiration: Depression of respiration or apnea may occur following too rapid intravenous administration or high doses of Ketamine .

Neurological: In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements.

Gastrointestinal: Anorexia, nausea and vomiting have been observed, however this is not usually severe and allows the great majority of patients to take liquids by mouth shortly after regaining consciousness.

Wake-up Phase: Some patients may experience some psychomimetic manifestations (bad dreams, hallucinations, and delirium) confusion and agitation.

It happens more often in adults, women, and alcoholics.

These manifestations could be avoided by previous administration of diazepam or droperidol.

 

Respiratory depression may occur with overdosage or too rapid administration of Ketamine, in which case, supportive ventilation should be employed.

Mechanical support of respiration is preferred to administration of analeptics.

 

As with other general anesthetic agents, the individual response to ketamine is somewhat varied, and the drug should be titrated against the patient’s requirements.

Intravenously: The initial dose ranges from 1- 4.5 mg/kg.

The average amount required to produce 5 –10 minutes of surgical anesthesia has been 2 mg/kg. Anesthesia begins during 30 seconds.

Rate of administration: It is recommended that Ketamine should be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.

Intramuscularly: The initial dose ranges from 6.5 – 13 mg/kg. Anesthesia begins during 3-4 minutes. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia.

Maintenance of anesthesia: Increments of one-half to the full induction dose may be repeated as needed.

To prepare a dilute solution containing 1 mg of Ketamine per 1 mL, aseptically transfer 10 mL of Ketamine (50 mg/mL) to 500 mL 5% dextrose injection or sodium chloride injection and mix well. If fluid restriction is required, Ketamine can be added to a 250-mL infusion as described above to provide a Ketamine concentration of 2 mg/mL.

Barbiturates and Ketamine, being chemically incompatible because of precipitate formation, should not be injected from the same syringe. Do not mix Ketamine and Diazepam in the same syringe or infusion flask.

 

- KETAMINE ELSaad 200 – Injection: A pack of 1 or 25 vials of 20 mL. Each  vial contains  Ketamine as Hydrochloride 10mg/mL.

- KETAMINE ELSaad 250 – Injection: A pack of 5 or 25 ampoules of 5 mL. Each  vial contains  Ketamine as Hydrochloride 50mg/mL.

- KETAMINE ELSaad 500 – Injection: A pack of 1 or 25 vials of 10 mL. Each  vial contains  Ketamine as Hydrochloride 50mg/mL.

 

Store KETAMINE ELSaad– Injection at temperature between (15-30)°C. Protect from light.