Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy

December 5, 2011 updated by: Jeong-Yeon Hong, Yonsei University
Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jeong-Yeon Hong, M.D.
          • Phone Number: 82-2-2228-2427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy

Exclusion Criteria:

  • cardiovascular, renal, liver disease or growth retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline
Group S (n = 15): saline
Drug: remifentanil
During surgery, 3 different dose of remifentanil or placebo was infused.
Experimental: remifentanil 0.3 mcg/kg/min
Group 0.3 (n = 15): remifentanil 0.3 mcg/kg/min
Drug: remifentanil
During surgery, 3 different dose of remifentanil or placebo was infused.
Experimental: remifentanil 0.6 mcg/kg/min
Group 0.6 (n = 15): remifentanil 0.6 mcg/kg/min
Drug: remifentanil
During surgery, 3 different dose of remifentanil or placebo was infused.
Experimental: remifentanil 0.9 mcg/kg/min
Group 0.9 (n = 15): remifentanil 0.9 mcg/kg/min
Drug: remifentanil
During surgery, 3 different dose of remifentanil or placebo was infused.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fentanyl consumption for IV-PCA
Time Frame: 24 h and 48 h after surgery
24 h and 48 h after surgery
Postoperative pain score
Time Frame: during 48 h after surgery
during 48 h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jeong-Yeon Hong, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 18, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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