The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

Hallym University

Status: Completed

Conditions: Adverse Effect of Other General Anesthetics

Treatments: Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium; Drug: Remifentanil; Other: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02486926

2012-I069

Details and patient eligibility

About

Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a cause of stress to both caregivers and families. Various pharmacologic agents have been suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This study was designed to compare the effects of remifentanil and remifentanil combining alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.

Full description

One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied. General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane. At the time of separation from parents, separation score was recorded. When the children have a separation score of three or four point, they received half dose of thiopental before going to the operation room. They randomly assigned to group S (sevoflurane alone) or group R (sevoflurane with remifentanil infusion at the rate of 0.1 ㎍/kg/min) or group A (sevoflurane with remifentanil infusion and intravenous injection of alfentanil 5 ㎍/kg 10 min before the end of surgery). Mean arterial pressure (MAP), heart rate (HR) and sevoflurane concentration were checked every 15 minutes after induction of anesthesia. Time to extubation from discontinuation of sevoflurane inhalation was measured. Time to discharge from postanesthesia care unit (PACU) was assessed with postanesthetic Aldrete recovery score. Emergence agitation scoring system was used to evaluate the incidence and severity of EA.

Enrollment: 102 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children who were scheduled to undergo ophthalmic surgery under general anesthesia

Exclusion criteria

• developmental delay, neurologic or psychologic disease,
• history of sleep apnea,
• or history of general anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 5 patient groups, including a placebo group

Sevoflurane

Placebo Comparator group

Description:

Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.

Treatment:

Other: Sevoflurane

Drug: Rocuronium

Drug: Thiopental

Remifentanil

Active Comparator group

Description:

Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.

Treatment:

Other: Sevoflurane

Drug: Remifentanil

Drug: Rocuronium

Drug: Thiopental

Alfentanil

Active Comparator group

Description:

Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group.

Treatment:

Drug: Alfentanil

Other: Sevoflurane

Drug: Remifentanil

Drug: Rocuronium

Drug: Thiopental

Thiopental

Other group

Description:

General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.

Treatment:

Drug: Alfentanil

Other: Sevoflurane

Drug: Remifentanil

Drug: Rocuronium

Drug: Thiopental

Rocuronium

Other group

Description:

General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.

Treatment:

Drug: Alfentanil

Other: Sevoflurane

Drug: Remifentanil

Drug: Rocuronium

Drug: Thiopental