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

NCT01506622 | Completed DMC

• 1 other identifier: 4-2010-0536
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Propofol group

ACTIVE COMPARATOR

intravenous administration of propofol 1 mg/kg at the end of anesthesia

Drug: Administration of propofol

Fentanyl group

ACTIVE COMPARATOR

intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia

Drug: Administration of fentanyl

Control group

ACTIVE COMPARATOR

intravenous administration of saline at the end of anesthesia

Drug: Administration of saline

Interventions

Administration of propofol DRUG

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

Propofol group

Administration of fentanyl DRUG

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

Fentanyl group

Administration of saline DRUG

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

Control group

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists I or II,
• months of age,
• scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia

You may not qualify if:

• developmental delay
• psychological and neurologic disorder
• sedatives medication
• an abnormal airway
• reactive airway disease
• extreme agitation and uncooperation
• previous history of anesthesia

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University

Seoul, South Korea

Location

Related 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.

  PMID: 20716081 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2011
• First Posted: January 10, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

KR (1)