This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: December 25, 2011
Last updated: July 14, 2015
Last verified: July 2015

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 Intervention
Emergence Agitation Drug: Administration of propofol Drug: Administration of fentanyl Drug: Administration of saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, Investigator)

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The incidence of emergence agitation [ Time Frame: 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

Enrollment: 222
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01506622

Korea, Republic of
Yonsei University
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01506622     History of Changes
Other Study ID Numbers: 4-2010-0536
Study First Received: December 25, 2011
Last Updated: July 14, 2015

Additional relevant MeSH terms:
Psychomotor Agitation
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia processed this record on July 21, 2017