Introduction

Opiate agonist; synthetic phenylpiperidine derivative.

Uses for SUFentanil

Anesthesia

As the analgesic component in the maintenance of balanced anesthesia (e.g., IV hypnotic and/or inhalation anesthetic, analgesic, skeletal muscle relaxant).

As the primary anesthetic agent for induction and maintenance of general anesthesia when used in conjunction with 100% oxygen and a skeletal muscle relaxant (e.g., pancuronium bromide, succinylcholine chloride).

Particularly useful when postoperative ventilation is anticipated and in providing favorable myocardial and cerebral oxygen balance.

Cardiovascular parameters generally are more stable intraoperatively with use of sufentanil compared with inhalation agents. Incidence of postoperative hypertension and requirements for vasoactive agents or postoperative analgesics generally are decreased following use of moderate or high doses of sufentanil as compared with use of inhalation agents.

Pain

Obstetric analgesia during labor and vaginal delivery.

SUFentanil Dosage and Administration

General

Premedication

• Selection of preanesthetic medication(s) should be based on the individual needs of the patient.

Administration

Administer by IV injection, intermittent or continuous IV infusion, or epidural injection.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administration of small volumes may require use of a tuberculin syringe or equivalent.

Rate of Administration

Administer by slow injection or intermittent or continuous infusion; individualize rate based on patient’s needs.

Concomitant Administration of a Neuromuscular Blocking Agent

Risk of muscular rigidity (particularly of the truncal muscles) is related to the dose and rate of the infusion; however, administration of a neuromuscular blocking agent prior to sufentanil therapy can reduce the risk.

The neuromuscular blocking agent used should be compatible with the patient’s condition, taking into account the hemodynamic effects of the drug, the cardiovascular status of the patient, existing drug therapy (e.g., preoperative use of β-adrenergic blocking agents), and the degree of skeletal muscle relaxation required.

Epidural Administration

For drug compatibility information, see Compatibility under Stability.

Specialized techniques are required for epidural administration; administration should be performed only by qualified individuals familiar with the techniques of administration, dosages, and special patient management problems associated with epidural administration.

Dosage

Available as sufentanil citrate; dosage expressed in terms of sufentanil.

Adjust dosage carefully according to body weight, individual requirements and response, physical status and underlying pathologic condition, premedication or concomitant medication(s), the anesthetic(s) being used, and the nature and duration of the surgery.

Administer additional doses when patient movement and/or changes in vital signs indicate surgical stress or lightening of analgesia, and adjust according to individual requirements, response, and the anticipated remaining duration of the surgical procedure.

Pediatric Patients

Anesthesia

General Anesthesia (as sole anesthetic agent) for Cardiovascular Surgery

Children <12 years of age: Initially, 10–25 mcg/kg in conjunction with 100% oxygen and a skeletal muscle relaxant. Additional doses of up to 25–50 mcg each (or, alternatively, 1–2 mcg/kg each) may be given as needed based on response to the initial dose and as determined by changes in vital signs that indicate surgical stress or lightening of anesthesia.

Neonates: Reduce dosage, especially in those with cardiovascular disease, according to the decrease in clearance. (See Pediatric Use under Cautions.)

Adults

Anesthesia

Analgesic Component of General Anesthesia

Minor surgical procedures (expected duration of anesthesia is 1–2 hours): Total dosage of 1–2 mcg/kg in conjunction with nitrous oxide and oxygen; ≥75% of the total dosage may be given by slow injection or infusion prior to intubation. May administer supplemental doses of 10–25 mcg or administer intermittent or continuous maintenance infusions as necessary when movement and/or changes in vital signs indicate surgical stress or lightening of anesthesia; adjust maintenance infusion rate so that total dosage does not exceed 1 mcg/kg per hour of expected surgical time.

Major surgical procedures (expected duration of anesthesia is 2–8 hours): Total dosage of 2–8 mcg/kg in conjunction with nitrous oxide and oxygen; ≤75% of the total dosage may be given by slow injection or infusion prior to intubation. May administer supplemental doses of 10–50 mcg or administer intermittent or continuous maintenance infusions as necessary when movement and/or changes in vital signs indicate surgical stress or lightening of anesthesia; adjust maintenance infusion rate so that total dosage does not exceed 1 mcg/kg per hour of expected surgical time.

General Anesthesia (as sole anesthetic agent)

Total dosage of 8–30 mcg/kg (by slow injection, infusion, or injection followed by infusion) in conjunction with oxygen and a skeletal muscle relaxant. Depending on the initial dose, may administer additional incremental doses of 0.5–10 mcg/kg by slow injection in anticipation of surgical stress (e.g., incision, sternotomy, cardiopulmonary bypass). Alternatively, may administer intermittent or continuous maintenance infusions as necessary as determined by changes in vital signs that indicate surgical stress and lightening of anesthesia; adjust maintenance infusion rate so that total dosage for the procedure does not exceed 30 mcg/kg.

Pain

Obstetric Analgesia

10–15 mcg (in combination with 10 mL of bupivacaine 0.125% with or without epinephrine). Doses may be repeated twice (for a total of 3 doses) at ≥1-hour intervals until delivery.

Prescribing Limits

Adults

Anesthesia

Analgesic Component of General Anesthesia

Minor or major surgical procedures: Total dose of ≤1 mcg/kg per hour of expected surgical time.

General Anesthesia (as sole anesthetic agent)

Total dose for procedure: ≤ 30 mcg/kg.

Special Populations

Hepatic Impairment

Adjust dosage carefully; elimination of the drug may be decreased.

Renal Impairment

Adjust dosage carefully; elimination of the drug may be decreased.

Geriatric and Debilitated Patients

Reduce initial dosage; adjust additional doses according to the initial response and desired effect.

Obese Patients

Base dosage on an estimate of ideal (lean) body weight if body weight exceeds ideal weight by >20%.

Contraindications

• Known hypersensitivity to sufentanil or intolerance to other opiate agonists.

Warnings/Precautions

Warnings

Shares the toxic potentials of the opiate agonists; observe the usual precautions of opiate agonist therapy.

Respiratory Depression

Respiratory function can be severely compromised.

Consider the possibility of a recurrence of respiratory depression during recovery. A secondary rise in plasma concentrations may occur during the recovery period as blood perfusion to peripheral tissues increases and drug redistribution occurs.

Administration of an opiate antagonist (e.g., naloxone) can reverse respiratory depression. The duration of respiratory depression produced by sufentanil may be longer than the duration of the opiate antagonist; therefore, continue appropriate patient monitoring following apparent initial reversal.

Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of sufentanil and benzodiazepines or other CNS depressants (e.g., anxiolytics, sedatives, hypnotics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opiate agonists, alcohol) may result in hypotension, decreased pulmonary arterial pressure, profound sedation, respiratory depression, coma, and death. (See Specific Drugs under Interactions.)

Supervised Administration

Should be administered only by individuals experienced in the use of parenteral anesthetics and in the maintenance of an adequate airway and respiratory support.

Opiate antagonist (e.g., naloxone) and facilities for intubation, administration of oxygen, and assisted or controlled respiration should be immediately available.

Monitor vital signs routinely during administration; facilities for postoperative monitoring and assisted or controlled respiration should be available following administration of anesthetic doses of the drug (i.e., ≥8 mcg/kg).

Major Toxicities

Musculoskeletal Effects

Possible skeletal muscle rigidity (e.g., of the truncal muscles); onset may be more rapid than with fentanyl. Administration of a neuromuscular blocking agent may be necessary. (See Concomitant Administration of a Neuromuscular Blocking Agent under Dosage and Administration.)

Adrenal Insufficiency

Adrenal insufficiency reported in patients receiving opiate agonists or opiate partial agonists. Manifestations are nonspecific and may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and hypotension.

If adrenal insufficiency is suspected, perform appropriate laboratory testing promptly and provide physiologic (replacement) dosages of corticosteroids; taper and discontinue the opiate agonist or partial agonist to allow recovery of adrenal function. If the opiate agonist or partial agonist can be discontinued, perform follow-up assessment of adrenal function to determine if corticosteroid replacement therapy can be discontinued. In some patients, switching to a different opiate improved symptoms.

General Precautions

CNS Effects

Caution in patients with head injuries; sufentanil may obscure the clinical course.

Impaired Respiration

Caution in patients with pulmonary disease, decreased respiratory reserve, or potentially compromised respiratory function. Further decreases in respiratory function and increases in airway resistance may occur.

Cardiovascular Effects

Generally produces few cardiovascular effects. Possible hypotension or hypertension. Bradycardia occurs infrequently during anesthesia and may be corrected by administration of atropine.

Hypogonadism

Hypogonadism or androgen deficiency reported in patients receiving long-term opiate agonist or opiate partial agonist therapy; causality not established. Manifestations may include decreased libido, impotence, erectile dysfunction, amenorrhea, or infertility. Perform appropriate laboratory testing in patients with manifestations of hypogonadism.

Specific Populations

Pregnancy

Category C.

Used epidurally for analgesia during labor and delivery. Not recommended for IV use during labor and delivery; avoid epidural dosages in excess of the recommended dosage.

Lactation

Not known whether sufentanil is distributed into milk. Caution if used in nursing women.

Pediatric Use

Safety and efficacy documented in a limited number of children ≥1 day of age undergoing cardiovascular surgery.

Use with caution in neonates because decreased clearance may result in increased blood concentrations of the drug. Clearance in healthy neonates is approximately one-half that reported in adults and children; may be further reduced by up to one-third in neonates with cardiovascular disease.

Geriatric Use

Consider dosage reduction. (See Geriatric and Debilitated Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution, since the drug undergoes metabolism in the liver.

Renal Impairment

Use with caution, since the drug and its metabolites are eliminated mainly by the kidneys.

Common Adverse Effects

Respiratory depression, skeletal muscle rigidity (e.g., truncal muscles, neck, extremities).

General

Premedication

• Selection of preanesthetic medication(s) should be based on the individual needs of the patient.

Administration

Administer by IV injection, intermittent or continuous IV infusion, or epidural injection.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administration of small volumes may require use of a tuberculin syringe or equivalent.

Rate of Administration

Administer by slow injection or intermittent or continuous infusion; individualize rate based on patient’s needs.

Concomitant Administration of a Neuromuscular Blocking Agent

Risk of muscular rigidity (particularly of the truncal muscles) is related to the dose and rate of the infusion; however, administration of a neuromuscular blocking agent prior to sufentanil therapy can reduce the risk.

The neuromuscular blocking agent used should be compatible with the patient’s condition, taking into account the hemodynamic effects of the drug, the cardiovascular status of the patient, existing drug therapy (e.g., preoperative use of β-adrenergic blocking agents), and the degree of skeletal muscle relaxation required.

Epidural Administration

For drug compatibility information, see Compatibility under Stability.

Specialized techniques are required for epidural administration; administration should be performed only by qualified individuals familiar with the techniques of administration, dosages, and special patient management problems associated with epidural administration.

Dosage

Available as sufentanil citrate; dosage expressed in terms of sufentanil.

Adjust dosage carefully according to body weight, individual requirements and response, physical status and underlying pathologic condition, premedication or concomitant medication(s), the anesthetic(s) being used, and the nature and duration of the surgery.

Administer additional doses when patient movement and/or changes in vital signs indicate surgical stress or lightening of analgesia, and adjust according to individual requirements, response, and the anticipated remaining duration of the surgical procedure.

Pediatric Patients

Anesthesia

General Anesthesia (as sole anesthetic agent) for Cardiovascular Surgery

Children <12 years of age: Initially, 10–25 mcg/kg in conjunction with 100% oxygen and a skeletal muscle relaxant. Additional doses of up to 25–50 mcg each (or, alternatively, 1–2 mcg/kg each) may be given as needed based on response to the initial dose and as determined by changes in vital signs that indicate surgical stress or lightening of anesthesia.

Neonates: Reduce dosage, especially in those with cardiovascular disease, according to the decrease in clearance. (See Pediatric Use under Cautions.)

Adults

Anesthesia

Analgesic Component of General Anesthesia

Minor surgical procedures (expected duration of anesthesia is 1–2 hours): Total dosage of 1–2 mcg/kg in conjunction with nitrous oxide and oxygen; ≥75% of the total dosage may be given by slow injection or infusion prior to intubation. May administer supplemental doses of 10–25 mcg or administer intermittent or continuous maintenance infusions as necessary when movement and/or changes in vital signs indicate surgical stress or lightening of anesthesia; adjust maintenance infusion rate so that total dosage does not exceed 1 mcg/kg per hour of expected surgical time.

Major surgical procedures (expected duration of anesthesia is 2–8 hours): Total dosage of 2–8 mcg/kg in conjunction with nitrous oxide and oxygen; ≤75% of the total dosage may be given by slow injection or infusion prior to intubation. May administer supplemental doses of 10–50 mcg or administer intermittent or continuous maintenance infusions as necessary when movement and/or changes in vital signs indicate surgical stress or lightening of anesthesia; adjust maintenance infusion rate so that total dosage does not exceed 1 mcg/kg per hour of expected surgical time.

General Anesthesia (as sole anesthetic agent)

Total dosage of 8–30 mcg/kg (by slow injection, infusion, or injection followed by infusion) in conjunction with oxygen and a skeletal muscle relaxant. Depending on the initial dose, may administer additional incremental doses of 0.5–10 mcg/kg by slow injection in anticipation of surgical stress (e.g., incision, sternotomy, cardiopulmonary bypass). Alternatively, may administer intermittent or continuous maintenance infusions as necessary as determined by changes in vital signs that indicate surgical stress and lightening of anesthesia; adjust maintenance infusion rate so that total dosage for the procedure does not exceed 30 mcg/kg.

Pain

Obstetric Analgesia

10–15 mcg (in combination with 10 mL of bupivacaine 0.125% with or without epinephrine). Doses may be repeated twice (for a total of 3 doses) at ≥1-hour intervals until delivery.

Prescribing Limits

Adults

Anesthesia

Analgesic Component of General Anesthesia

Minor or major surgical procedures: Total dose of ≤1 mcg/kg per hour of expected surgical time.

General Anesthesia (as sole anesthetic agent)

Total dose for procedure: ≤ 30 mcg/kg.

Special Populations

Hepatic Impairment

Adjust dosage carefully; elimination of the drug may be decreased.

Renal Impairment

Adjust dosage carefully; elimination of the drug may be decreased.

Geriatric and Debilitated Patients

Reduce initial dosage; adjust additional doses according to the initial response and desired effect.

Obese Patients

Base dosage on an estimate of ideal (lean) body weight if body weight exceeds ideal weight by >20%.

Drugs Associated with Serotonin Syndrome

Risk of serotonin syndrome when used with other serotonergic drugs. May occur at usual dosages. Symptom onset generally occurs within several hours to a few days of concomitant use, but may occur later, particularly after dosage increases. (See Advice to Patients.)

If concomitant use of other serotonergic drugs is warranted, monitor patients for serotonin syndrome, particularly during initiation of therapy and dosage increases.

If serotonin syndrome is suspected, discontinue sufentanil, other opiate therapy, and/or any concurrently administered serotonergic agents.

Specific Drugs