Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01506622
Enrollment
222
Registered
2012-01-10
Start date
2011-01-31
Completion date
2011-12-31
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

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.

Interventions

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

DRUGAdministration of fentanyl

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

DRUGAdministration of saline

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Months to 72 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of emergence agitationParticipants 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026