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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Administration of propofol; Drug: Administration of fentanyl; Drug: Administration of saline

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: December 25, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (ESTIMATE): January 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Propofol
• Other Study ID Numbers: 4-2010-0536