NCT01147757

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

June 17, 2010

Last Update Submit

December 5, 2011

Conditions

Pediatrics

Keywords

pediatric patients (ASA physical status I or II) aged between

Outcome Measures

Primary Outcomes (2)

  • fentanyl consumption for IV-PCA

    24 h and 48 h after surgery

  • Postoperative pain score

    during 48 h after surgery

Study Arms (4)

saline

PLACEBO COMPARATOR

Group S (n = 15): saline

Drug: remifentanil

remifentanil 0.3 mcg/kg/min

EXPERIMENTAL

Group 0.3 (n = 15): remifentanil 0.3 mcg/kg/min

Drug: remifentanil

remifentanil 0.6 mcg/kg/min

EXPERIMENTAL

Group 0.6 (n = 15): remifentanil 0.6 mcg/kg/min

Drug: remifentanil

remifentanil 0.9 mcg/kg/min

EXPERIMENTAL

Group 0.9 (n = 15): remifentanil 0.9 mcg/kg/min

Drug: remifentanil

Interventions

remifentanilDRUG

During surgery, 3 different dose of remifentanil or placebo was infused.

remifentanil 0.3 mcg/kg/minremifentanil 0.6 mcg/kg/minremifentanil 0.9 mcg/kg/minsaline

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • cardiovascular, renal, liver disease or growth retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jeong-Yeon Hong

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Yeon Hong

CONTACT

jenyhongg@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

KR(1)