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

Not Applicable

Completed

• Conditions: Emergence Agitation
• Interventions: Drug: Administration of propofol; Drug: Administration of saline; Drug: Administration of fentanyl

• Registration Number: NCT01506622
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-25
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Administration of propofol	intravenous administration of propofol 1 mg/kg at the end of anesthesia
Control group	Administration of saline	intravenous administration of saline at the end of anesthesia
Fentanyl group	Administration of fentanyl	intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia

Primary Outcome Measures

Name	Time	Method
The incidence of emergence agitation	Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.	The investigator will evaluate the incidence and extent of emergence agitation of participants, according to Aono's scale, the 5-step Emergence Agitation (EA) scale. Also, the Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess emergence agitation. Aono's scale scores ≥3, 5-step (EA) scale ≥4 or PAED scale scores ≥10 will be considered as presence of emergence agitation

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of