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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Jeong-Yeon Hong, Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01147757
First Posted: June 22, 2010
Last Update Posted: December 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeong-Yeon Hong, Yonsei University
  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 (Participant, Care Provider)

Resource links provided by NLM:


Further study details as provided by Jeong-Yeon Hong, Yonsei University:

Primary Outcome Measures:
  • fentanyl consumption for IV-PCA [ Time Frame: 24 h and 48 h after surgery ]
  • Postoperative pain score [ Time Frame: during 48 h after surgery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Jeong-Yeon Hong, associate professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01147757     History of Changes
Other Study ID Numbers: 4-2010-0129
First Submitted: June 17, 2010
First Posted: June 22, 2010
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by Jeong-Yeon Hong, Yonsei University:
pediatric patients (ASA physical status I or II) aged between

Additional relevant MeSH terms:
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