Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Strabismus
• Intervention / Treatment: Drug: High dose remifentanil; Drug: Low dose remifentanil; Drug: No remifentanil

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 612-896
    • Haeundae paik hospital, inje university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: No remifentanil (Ultiva, Glaxosmithkline, UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative vomiting in PACU and surgical ward	Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.	from extubation to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain in PACU and surgical ward	Postoperative pain will be assessed using Faces Pain Rating Scale.	from extubation to 24 hours
postoperative emergence agitation	Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.	from extubation to 24 hours

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: Lee, M.D., Inje University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Postoperative Vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Signs and Symptoms, Digestive; Cranial Nerve Diseases; Ocular Motility Disorders; Nausea; Vomiting; Strabismus; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 2015-024 (Other Identifier: Wayne State University/Karmanos Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO