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Clinical Trials/NCT02486926
NCT02486926
Completed
Not Applicable

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

Hallym University Medical Center0 sites102 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Sevoflurane
Conditions
Adverse Effect of Other General Anesthetics
Sponsor
Hallym University Medical Center
Enrollment
102
Primary Endpoint
the incidence of emergence agitation
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
January 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Sevoflurane

Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.

Intervention: Sevoflurane

Sevoflurane

Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.

Intervention: Thiopental

Sevoflurane

Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.

Intervention: Rocuronium

Remifentanil

Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Sevoflurane

Remifentanil

Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Remifentanil

Remifentanil

Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Thiopental

Remifentanil

Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Rocuronium

Alfentanil

Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Sevoflurane

Alfentanil

Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Remifentanil

Alfentanil

Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Alfentanil

Alfentanil

Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Thiopental

Alfentanil

Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group.

Intervention: Rocuronium

Thiopental

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

Intervention: Sevoflurane

Thiopental

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

Intervention: Remifentanil

Thiopental

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

Intervention: Alfentanil

Thiopental

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

Intervention: Thiopental

Thiopental

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

Intervention: Rocuronium

Rocuronium

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

Intervention: Sevoflurane

Rocuronium

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

Intervention: Remifentanil

Rocuronium

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

Intervention: Alfentanil

Rocuronium

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

Intervention: Thiopental

Rocuronium

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

Intervention: Rocuronium

Outcomes

Primary Outcomes

the incidence of emergence agitation

Time Frame: during recovery time in PACU (within 1 hour)

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