Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia

Yonsei University

Status: Completed

Conditions: Emergence Agitation

Treatments: Drug: Administration of fentanyl; Drug: Administration of saline; Drug: Administration of propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01506622

4-2010-0536

Details and patient eligibility

About

The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.

Many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. The typical agents that can be administered in this way are propofol and fentanyl.

Previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of EA.

The purpose of this study is to compare the preventive effect on EA and the characteristics of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane anesthesia.

Enrollment: 222 patients

Sex: All

Ages: 18 to 72 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists I or II,
• 18-72 months of age,
• scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia

Exclusion criteria

• developmental delay
• psychological and neurologic disorder
• sedatives medication
• an abnormal airway
• reactive airway disease
• extreme agitation and uncooperation
• previous history of anesthesia

Trial design

222 participants in 3 patient groups

Propofol group

Active Comparator group

Description:

intravenous administration of propofol 1 mg/kg at the end of anesthesia

Treatment:

Drug: Administration of propofol

Fentanyl group

Active Comparator group

Description:

intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia

Treatment:

Drug: Administration of fentanyl

Control group

Active Comparator group

Description:

intravenous administration of saline at the end of anesthesia

Treatment:

Drug: Administration of saline