The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children
Information source: Hallym University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adverse Effect of Other General Anesthetics
Intervention: Sevoflurane (Other); Remifentanil (Drug); Alfentanil (Drug); Thiopental (Drug); Rocuronium (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hallym University Medical Center Official(s) and/or principal investigator(s):
Soo Kyung Lee, M.D., Study Chair, Affiliation: Department of Anesthesiology and Pain Medicine, Hallyum University Sacred Heart Hospital
Summary
Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating
airway properties, rapid induction and emergence. However, it is associated with emergence
agitation (EA) in children. EA may cause injury to the child or to the surgical site and is
a cause of stress to both caregivers and families. Various pharmacologic agents have been
suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This
study was designed to compare the effects of remifentanil and remifentanil combining
alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.
Clinical Details
Official title: The Effects of Remifentanil and Remifentanil-Alfentanil Administration on Emergence Agitation After Brief Ophthalmic Surgery in Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: the incidence of emergence agitation
Detailed description:
One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied.
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0. 6 mg/kg and
sevoflurane. At the time of separation from parents, separation score was recorded. When the
children have a separation score of three or four point, they received half dose of
thiopental before going to the operation room. They randomly assigned to group S
(sevoflurane alone) or group R (sevoflurane with remifentanil infusion at the rate of 0. 1
㎍/kg/min) or group A (sevoflurane with remifentanil infusion and intravenous injection of
alfentanil 5 ㎍/kg 10 min before the end of surgery). Mean arterial pressure (MAP), heart
rate (HR) and sevoflurane concentration were checked every 15 minutes after induction of
anesthesia. Time to extubation from discontinuation of sevoflurane inhalation was measured.
Time to discharge from postanesthesia care unit (PACU) was assessed with postanesthetic
Aldrete recovery score. Emergence agitation scoring system was used to evaluate the
incidence and severity of EA.
Eligibility
Minimum age: 3 Years.
Maximum age: 9 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- children who were scheduled to undergo ophthalmic surgery under general anesthesia
Exclusion Criteria:
- developmental delay, neurologic or psychologic disease,
- history of sleep apnea,
- or history of general anesthesia
Locations and Contacts
Additional Information
Related publications: Ozturk T, Erbuyun K, Keles GT, Ozer M, Yuksel H, Tok D. The effect of remifentanil on the emergence characteristics of children undergoing FBO for bronchoalveolar lavage with sevoflurane anaesthesia. Eur J Anaesthesiol. 2009 Apr;26(4):338-42. doi: 10.1097/EJA.0b013e32831de50d.
Starting date: November 2012
Last updated: July 2, 2015
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