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The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

The Effects of Remifentanil and Remifentanil-Alfentanil Administration on Emergence Agitation After Brief Ophthalmic Surgery in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02486926
Enrollment
102
Registered
2015-07-01
Start date
2012-11-30
Completion date
2014-01-31
Last updated
2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Other General Anesthetics

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.

Interventions

OTHERSevoflurane

Anesthesia of patients was maintained only with sevoflurane.

DRUGRemifentanil

Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.

DRUGAlfentanil

Anesthesia was maintained with both sevoflurane and continuous infusion of remifentanil. Alfentanil was administrated (5ug/kg) to patients 10 minutes before the end of surgery.

General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.

DRUGRocuronium

General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.

Sponsors

Hallym University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the incidence of emergence agitationduring recovery time in PACU (within 1 hour)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026