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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01506622

Collaborator

(none)

222

Enrollment

Location

Arms

Duration (Months)

20.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Agitation	Drug: Administration of propofol Drug: Administration of fentanyl Drug: Administration of saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 72 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01506622

Other Study ID Numbers:

4-2010-0536

First Posted:

Jan 10, 2012

Last Update Posted:

Jul 16, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Psychomotor Agitation

Emergence Delirium

Fentanyl

Propofol

Study Results

No Results Posted as of Jul 16, 2015