Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery
Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Strabismus
Intervention: High dose remifentanil (Drug); Low dose remifentanil (Drug); No remifentanil (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Inje University Official(s) and/or principal investigator(s):
Lee, M.D., Principal Investigator, Affiliation: Inje University
Overall contact:
Kyung Mi Kim, M.D., Phone: +82-10-4083-5318, Email: sumsonyo@gmail.com
Summary
The purpose of this study is to compare the effect of remifentanil on postoperative vomiting
in children undergoing strabismus surgery during sevoflurane anesthesia.
Clinical Details
Official title: Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: incidence of postoperative vomiting in PACU and surgical ward
Secondary outcome: postoperative pain in PACU and surgical wardpostoperative emergence agitation
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.
Eligibility
Minimum age: 3 Years.
Maximum age: 6 Years.
Gender(s): Both.
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
Locations and Contacts
Kyung Mi Kim, M.D., Phone: +82-10-4083-5318, Email: sumsonyo@gmail.com
Haeundae paik hospital, inje university, Busan 612-896, Korea, Republic of; Recruiting
Ki Hwa Lee, MD, Phone: 82-51-797-0426, Email: tedy333@paik.ac.kr
Ki Hwa Lee, MD, Sub-Investigator
Additional Information
Starting date: May 2015
Last updated: June 26, 2015
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