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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 Yonsei University.
Recruitment status was:  Recruiting
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
  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:


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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
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 
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
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

ClinicalTrials.gov processed this record on December 08, 2016