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Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02163980
Enrollment
80
Registered
2014-06-16
Start date
2011-05-31
Completion date
2011-07-31
Last updated
2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Orchipexy

Keywords

dexmedetomidine, caudal block, children, children (1-6 years) undergoing ambulatory orchipexy

Brief summary

The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.

Interventions

DRUGCaudal ropivacaine + normal saline
DRUGCaudal ropivacaine + dexmedetomidine

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
1 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* children undergoing ambulatory orchiopexy, * ASA status I

Exclusion criteria

* mental retardation, * developmental delay, * neurological or psychiatric illness, * coagulation disorder, * spinal anomalies

Design outcomes

Primary

MeasureTime frameDescription
vital signup to 180 min after surgerysystolic arterial pressure

Secondary

MeasureTime frameDescription
inhalation anesthetics requirementsup to 180 min after surgeryend-tidal sevoflurane concentration required to maintain hemodynamic changes \< 20% of the preoperative baseline

Other

MeasureTime frameDescription
incidence of agitationup to 180 min after surgerynumber of patients
sedation scoreup to 180 min after surgerythree-point scale (0=eyes open spontaneously, 1=verbal stimulation, 2=physical stimulation
pain scoresup to 180 min after surgeryFace Legs Activity Cry, Consolability scale (FLACC) Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026