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Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

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ClinicalTrials.gov Identifier: NCT02455401
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Brief Summary:
The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.

Condition or disease Intervention/treatment Phase
Strabismus Drug: High dose remifentanil Drug: Low dose remifentanil Drug: No remifentanil Not Applicable

Detailed Description:
Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study Start Date : May 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: high dose remifentanil group
Intervention: high dose remifentanil will be administrated.
Drug: High dose remifentanil
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes
Other Name: High dose remifentanil (Ultiva,Glaxosmithkline, UK)

Experimental: low dose remifentanil group
Intervention: low dose remifentanil will be administrated
Drug: Low dose remifentanil
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes
Other Name: Low dose remifentanil (Ultiva, Glaxosmithkline, UK)

Placebo Comparator: No remifentanil group
Intervention: no remifenatnil will be administrated
Drug: No remifentanil
Intervention: no remifentanil will be administrated
Other Name: No remifentanil (Ultiva, Glaxosmithkline, UK)




Primary Outcome Measures :
  1. incidence of postoperative vomiting in PACU and surgical ward [ Time Frame: from extubation to 24 hours ]
    Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.


Secondary Outcome Measures :
  1. postoperative pain in PACU and surgical ward [ Time Frame: from extubation to 24 hours ]
    Postoperative pain will be assessed using Faces Pain Rating Scale.

  2. postoperative emergence agitation [ Time Frame: from extubation to 24 hours ]
    Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children undergoing elective strabismus surgery under sevoflurane anesthesia

Exclusion Criteria:

  • children who experienced postoperative retching or vomiting
  • children who have taken anti-emetic medications within 24 hours before surgery
  • children who experienced motion sickness

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): NCT02455401


Locations
Korea, Republic of
Haeundae paik hospital, inje university
Busan, Korea, Republic of, 612-896
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Lee, M.D. Inje University

Responsible Party: Ki Hwa Lee, Assistant Professor, Inje University
ClinicalTrials.gov Identifier: NCT02455401     History of Changes
Other Study ID Numbers: 2015-024
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ki Hwa Lee, Inje University:
Postoperative Vomiting

Additional relevant MeSH terms:
Vomiting
Strabismus
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Nausea
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics