ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02152787
Recruitment Status : Unknown
Verified July 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : June 2, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Strabismus Drug: Injection of propofol 1.0mg/kg Drug: propofol 0.5mg/kg Drug: normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Propofol 1mg/kg and Propofol 0.5mg/kg for Prevention of Emergence Agitation in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: 1) propofol 1.0mg/kg group
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
Experimental: 2) propofol 0.5mg/kg group
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
Placebo Comparator: 3) normal saline group
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



Primary Outcome Measures :
  1. The incidence of the emergence agitation [ Time Frame: from extubation up to 1 hour ]

Secondary Outcome Measures :
  1. the emergence time [ Time Frame: within the first 1hour after end of strabismus surgery ]
    The emergence time was defined as the time from discontinuation of sevoflurane to extubation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152787


Contacts
Contact: Min-Soo KIM, MD 02-2019-3522 kmsviola@yuhs.ac

Locations
Korea, Republic of
Gangnam Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Min-Soo KIM, MD    02-2019-3522    kmsviola@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02152787     History of Changes
Other Study ID Numbers: 3-2014-0028
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Yonsei University:
emergence agitation
propofol
strabismus surgery
children
elective strabismus surgery

Additional relevant MeSH terms:
Psychomotor Agitation
Strabismus
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation