An interventional study of Administration of propofol and Administration of fentanyl in Emergence Agitation, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Months to 72 Months. Per ClinicalTrials.gov, last updated 2015-07-16.
Sponsored by Yonsei University · Not applicable and Interventional
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 222 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
intravenous administration of propofol 1 mg/kg at the end of anesthesia
Drug: Administration of propofol
intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia
Drug: Administration of fentanyl
intravenous administration of saline at the end of anesthesia
Drug: Administration of saline
Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.
Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.
Saline will be administered to control group at the end of anesthesia.
The incidence of emergence agitation
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
Time frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Yonsei University