Clinical trial NCT02486926: The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children
Official title: The Effects of Remifentanil and Remifentanil-Alfentanil Administration on Emergence Agitation After Brief Ophthalmic Surgery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect of Other General Anesthetics
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 102
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: the incidence of emergence agitation
timeFrame: during recovery time in PACU (within 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Hallyum University Sacred Heart Hospital
name: Soo Kyung Lee, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: Choi YH, Kim KM, Lee SK, Kim YS, Kim SJ, Hwang WS, Chung JH. Effects of remifentanil and remifentanil-alfentanil administration on emergence agitation after brief ophthalmic surgery in children. BMC Anesthesiol. 2016 Aug 2;16(1):50. doi: 10.1186/s12871-016-0213-2.