The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

NCT02486926 | Completed DMC

• 1 other identifier: 2012-I069
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Effect of Other General Anesthetics

Outcome Measures

Primary Outcomes (1)

• the incidence of emergence agitation

  during recovery time in PACU (within 1 hour)

Study Arms (5)

Sevoflurane

PLACEBO COMPARATOR

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

Other: Sevoflurane; Drug: Thiopental; Drug: Rocuronium

Remifentanil

ACTIVE COMPARATOR

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

Other: Sevoflurane; Drug: Remifentanil; Drug: Thiopental; Drug: Rocuronium

Alfentanil

ACTIVE COMPARATOR

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; Drug: Remifentanil; Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium

Thiopental

OTHER

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

Other: Sevoflurane; Drug: Remifentanil; Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium

Rocuronium

OTHER

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

Other: Sevoflurane; Drug: Remifentanil; Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium

Interventions

Sevoflurane OTHER

Anesthesia of patients was maintained only with sevoflurane.

Alfentanil; Remifentanil; Rocuronium; Sevoflurane; Thiopental

Remifentanil DRUG

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

Also known as: Ultiva

Alfentanil; Remifentanil; Rocuronium; Thiopental

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.

Alfentanil; Rocuronium; Thiopental

Thiopental DRUG

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

Also known as: Pentothal sodium

Alfentanil; Remifentanil; Rocuronium; Sevoflurane; Thiopental

Rocuronium DRUG

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

Also known as: Esmeron

Alfentanil; Remifentanil; Rocuronium; Sevoflurane; Thiopental

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children who were scheduled to undergo ophthalmic surgery under general anesthesia

You may not qualify if:

• developmental delay, neurologic or psychologic disease,
• history of sleep apnea,
• or history of general anesthesia

Sponsors & Collaborators

• Hallym University Medical Center: lead

Related Publications (2)

• 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.

  PMID: 19401665 BACKGROUND

• 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.

  PMID: 27484339 DERIVED

MeSH Terms

Interventions

Sevoflurane; Remifentanil; Alfentanil; Thiopental; Rocuronium

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Soo Kyung Lee, M.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 7, 2015

Record last verified: 2015-07