The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

Study 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.

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

Conditions
-----------------
Adverse Effect of Other General Anesthetics

Intervention / Treatment
-----------------
* Other: Sevoflurane
* Drug: Remifentanil
* Drug: Alfentanil
* Drug: Thiopental
* Drug: Rocuronium


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sevoflurane<br>Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated. | Other: Sevoflurane<br>* Anesthesia of patients was maintained only with sevoflurane.<br>Drug: Thiopental<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Pentothal sodium;Drug: Rocuronium<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Esmeron;|
| Active Comparator: Remifentanil<br>Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group. | Other: Sevoflurane<br>* Anesthesia of patients was maintained only with sevoflurane.<br>Drug: Remifentanil<br>* Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.<br>* Other names: Ultiva;Drug: Thiopental<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Pentothal sodium;Drug: Rocuronium<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Esmeron;|
| Active Comparator: Alfentanil<br>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. | Other: Sevoflurane<br>* Anesthesia of patients was maintained only with sevoflurane.<br>Drug: Remifentanil<br>* Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.<br>* Other names: Ultiva;Drug: Alfentanil<br>* 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.<br>Drug: Thiopental<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Pentothal sodium;Drug: Rocuronium<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Esmeron;|
| Other: Thiopental<br>General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. | Other: Sevoflurane<br>* Anesthesia of patients was maintained only with sevoflurane.<br>Drug: Remifentanil<br>* Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.<br>* Other names: Ultiva;Drug: Alfentanil<br>* 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.<br>Drug: Thiopental<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Pentothal sodium;Drug: Rocuronium<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Esmeron;|
| Other: Rocuronium<br>General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. | Other: Sevoflurane<br>* Anesthesia of patients was maintained only with sevoflurane.<br>Drug: Remifentanil<br>* Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.<br>* Other names: Ultiva;Drug: Alfentanil<br>* 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.<br>Drug: Thiopental<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Pentothal sodium;Drug: Rocuronium<br>* General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.<br>* Other names: Esmeron;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of emergence agitation |  | during recovery time in PACU (within 1 hour) |