Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia
|ClinicalTrials.gov Identifier: NCT01506622|
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : July 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Emergence Agitation||Drug: Administration of propofol Drug: Administration of fentanyl Drug: Administration of saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Propofol group
intravenous administration of propofol 1 mg/kg at the end of anesthesia
Drug: Administration of propofol
Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.
Active Comparator: Fentanyl group
intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia
Drug: Administration of fentanyl
Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.
Active Comparator: Control group
intravenous administration of saline at the end of anesthesia
Drug: Administration of saline
Saline will be administered to control group at the end of anesthesia.
- The incidence of emergence agitation [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506622
|Korea, Republic of|
|Seoul, Korea, Republic of|