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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506622
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : July 16, 2015
Information provided by (Responsible Party):
Yonsei University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506622

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

Responsible Party: Yonsei University Identifier: NCT01506622     History of Changes
Other Study ID Numbers: 4-2010-0536
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
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