The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

July 2, 2015 updated by: Hallym University Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Study Chair: Soo Kyung Lee, M.D., Department of Anesthesiology and Pain Medicine, Hallyum University Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-I069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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