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

This study is currently recruiting participants.
Verified December 2011 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Jeong-Yeon Hong, Yonsei University
ClinicalTrials.gov Identifier:
NCT01147757
First received: June 17, 2010
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.


Condition Intervention
Pediatrics
 Drug: remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • fentanyl consumption for IV-PCA [ Time Frame: 24 h and 48 h after surgery ] [ Designated as safety issue: No ]
  • Postoperative pain score [ Time Frame: during 48 h after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147757

Contacts
Contact: Jeong-Yeon Hong jenyhongg@hanmail.net

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong-Yeon Hong, M.D.     82-2-2228-2427        
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Jeong-Yeon Hong Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Jeong-Yeon Hong, associate professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01147757     History of Changes
Other Study ID Numbers: 4-2010-0129
Study First Received: June 17, 2010
Last Updated: December 5, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
pediatric patients (ASA physical status I or II) aged between

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on June 18, 2013