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Completed

NCT Number: NCT02486926

The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

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.

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Key information

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sevoflurane

Other

Anesthesia of patients was maintained only with sevoflurane.

Remifentanil

Drug

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

Other names: Ultiva

alfentanil

Drug

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.

Thiopental

Drug

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

Other names: Pentothal sodium

Rocuronium

Drug

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

Other names: Esmeron

Primary outcomes

  1. the incidence of emergence agitation

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

Sponsors and collaborators

Lead sponsor

Hallym University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 1, 2015
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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