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

Emergence Agitation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506622
• Other study ID #: 4-2010-0536
• Status: Completed
• Phase: N/A
• First received: December 25, 2011
• Last updated: July 14, 2015
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 72 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

• Emergence Agitation
• Psychomotor Agitation

Intervention

Drug:
• Administration of propofol
Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.
• Administration of fentanyl
Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.
• Administration of saline
Saline will be administered to control group at the end of anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.	No