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

This study is currently recruiting participants.
Verified January 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01506622
First received: December 25, 2011
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)

Resource links provided by NLM:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 222
Study Start Date: January 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: January 2012 (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.

  Eligibility

Ages Eligible for Study:   18 Months to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506622

Contacts
Contact: Jeong-Rim Lee, MD, PhD 02-2227-3840 MANYA@yuhs.ac

Locations
Korea, Republic of
Yonsei University Recruiting
Seoul, Korea, Republic of
Contact: Jeong-Rim Lee, MD, PhD     02-2227-3840     MANYA@yuhs.ac    
Principal Investigator: Jeong-Rim Lee, MD, PhD            
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01506622     History of Changes
Other Study ID Numbers: 4-2010-0536
Study First Received: December 25, 2011
Last Updated: January 9, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Fentanyl
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 19, 2013