NCT01578174

Brief Summary

The investigators examined the effect of dexmedetomidine in the management of pain after uterine artery embolization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

April 13, 2012

Last Update Submit

January 16, 2018

Conditions

Pain Control

Outcome Measures

Primary Outcomes (1)

  • Fentanyl consumption by patient-controlled analgesia

    24 hours

Secondary Outcomes (1)

  • Side effects

    24 hours

Study Arms (2)

Control

PLACEBO COMPARATOR
Drug: Normal saline 0.9%

Dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexmedetomidine(Dexmedetomidine 2 mL and normal saline 98 mL mixed -\> 2㎍/mL) : the infusion of 0.2㎍/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4㎍/kg/hr after completion of procedure

Dexmedetomidine
Normal saline 0.9%DRUG

Normal saline 100mL(guess as 2㎍/mL):the infusion of 0.2㎍/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4㎍/kg/hr after completion of procedure

Control

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 20,
  • ASA class I and II

You may not qualify if:

  • bradycardia (\< 45 bpm)
  • heart block
  • liver failure
  • renal failure
  • uncontrolled hypertension
  • body mass index ≥ 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Agnosia

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 16, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

KR(1)