The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

NCT ID: NCT02486926

Last Updated: 2015-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Adverse Effect of Other General Anesthetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sevoflurane

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

Group Type PLACEBO_COMPARATOR

Sevoflurane

Intervention Type OTHER

Anesthesia of patients was maintained only with sevoflurane.

Thiopental

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

Remifentanil

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type OTHER

Anesthesia of patients was maintained only with sevoflurane.

Remifentanil

Intervention Type DRUG

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

Thiopental

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type OTHER

Anesthesia of patients was maintained only with sevoflurane.

Remifentanil

Intervention Type DRUG

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

Alfentanil

Intervention Type 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

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

Thiopental

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

Group Type OTHER

Sevoflurane

Intervention Type OTHER

Anesthesia of patients was maintained only with sevoflurane.

Remifentanil

Intervention Type DRUG

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

Alfentanil

Intervention Type 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

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

Rocuronium

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

Group Type OTHER

Sevoflurane

Intervention Type OTHER

Anesthesia of patients was maintained only with sevoflurane.

Remifentanil

Intervention Type DRUG

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

Alfentanil

Intervention Type 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

Intervention Type DRUG

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

Rocuronium

Intervention Type DRUG

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

Interventions

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Sevoflurane

Anesthesia of patients was maintained only with sevoflurane.

Intervention Type OTHER

Remifentanil

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

Intervention Type 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.

Intervention Type DRUG

Thiopental

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

Intervention Type DRUG

Rocuronium

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

Intervention Type DRUG

Other Intervention Names

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Ultiva Pentothal sodium Esmeron

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soo Kyung Lee, M.D.

Role: STUDY_CHAIR

Department of Anesthesiology and Pain Medicine, Hallyum University Sacred Heart Hospital

References

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Ozturk T, Erbuyun K, Keles GT, Ozer M, Yuksel H, Tok D. The effect of remifentanil on the emergence characteristics of children undergoing FBO for bronchoalveolar lavage with sevoflurane anaesthesia. Eur J Anaesthesiol. 2009 Apr;26(4):338-42. doi: 10.1097/EJA.0b013e32831de50d.

Reference Type BACKGROUND
PMID: 19401665 (View on PubMed)

Choi YH, Kim KM, Lee SK, Kim YS, Kim SJ, Hwang WS, Chung JH. Effects of remifentanil and remifentanil-alfentanil administration on emergence agitation after brief ophthalmic surgery in children. BMC Anesthesiol. 2016 Aug 2;16(1):50. doi: 10.1186/s12871-016-0213-2.

Reference Type DERIVED
PMID: 27484339 (View on PubMed)

Other Identifiers

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2012-I069

Identifier Type: -

Identifier Source: org_study_id

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