Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

NCT02152787 | Unknown

• 1 other identifier: 3-2014-0028
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. Among various strategies for reducing the incidence and severity of EA, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. The one of typical agents that can be administered in this way is propofol. Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. The purpose of this study is to compare the preventive effect on EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.

Conditions

Strabismus

Keywords

emergence agitation; propofol; strabismus surgery; children; elective strabismus surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of the emergence agitation

  from extubation up to 1 hour

Secondary Outcomes (1)

• the emergence time

  within the first 1hour after end of strabismus surgery

Study Arms (3)

1) propofol 1.0mg/kg group

EXPERIMENTAL

According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

Drug: Injection of propofol 1.0mg/kg

2) propofol 0.5mg/kg group

EXPERIMENTAL

According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

Drug: propofol 0.5mg/kg

3) normal saline group

PLACEBO COMPARATOR

According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery

Drug: normal saline

Interventions

Injection of propofol 1.0mg/kg DRUG

1) propofol 1.0mg/kg group

propofol 0.5mg/kg DRUG

2) propofol 0.5mg/kg group

normal saline DRUG

3) normal saline group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia.
• ASA 1-2

You may not qualify if:

• \. Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Conditions

Strabismus; Emergence Delirium

Interventions

Propofol; Saline Solution

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Min-Soo KIM, MD

CONTACT

02-2019-3522; kmsviola@yuhs.ac

Study Design

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

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

KR (1)