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

NCT ID: NCT01506622

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Emergence Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Propofol group

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

Group Type: ACTIVE_COMPARATOR

Administration of propofol

Intervention Type: DRUG

Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.

Fentanyl group

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

Group Type: ACTIVE_COMPARATOR

Administration of fentanyl

Intervention Type: DRUG

Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.

Control group

intravenous administration of saline at the end of anesthesia

Group Type: ACTIVE_COMPARATOR

Administration of saline

Intervention Type: DRUG

Saline will be administered to control group at the end of anesthesia.

Interventions

Administration of propofol

Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.

Intervention Type: DRUG

Administration of fentanyl

Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.

Intervention Type: DRUG

Administration of saline

Saline will be administered to control group at the end of anesthesia.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University

Seoul, , South Korea

Countries

South Korea

References

Chen J, Li W, Hu X, Wang D. Emergence agitation after cataract surgery in children: a comparison of midazolam, propofol and ketamine. Paediatr Anaesth. 2010 Sep;20(9):873-9. doi: 10.1111/j.1460-9592.2010.03375.x.

Reference Type: BACKGROUND

PMID: 20716081 (View on PubMed)

Other Identifiers

4-2010-0536

Identifier Type: -

Identifier Source: org_study_id