NCT02784626

Brief Summary

In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

May 22, 2016

Last Update Submit

October 25, 2016

Conditions

Arthritis, Degenerative

Keywords

DexmedetomidinePropofolPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    Postoperative pain score at postoperative 24 hours

    Postoperative 24 hours

Secondary Outcomes (3)

  • Rescue analgesics

    Postoperative 24 hours

  • Rescue analgesics

    Postoperative 48 hours

  • Visual analogue scale

    Postoperative 48 hours

Other Outcomes (5)

  • Nausea and vomiting

    Postoperative 24 hours

  • Nausea and vomiting

    Postoperative 48 hours

  • Antiemetics

    Postoperative 24 hours

  • +2 more other outcomes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Patients who received dexmedetomidine during the operation

Drug: Dexmedetomidine

Propofol

EXPERIMENTAL

Patients who received propofol during the operation

Drug: Propofol

Interventions

DexmedetomidineDRUG

Intraoperative sedation using dexmedetomidine

Dexmedetomidine
PropofolDRUG

Intraoperative sedation using propofol

Propofol

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing total knee arthroplasty
  • Age: 20 - 80 yrs

You may not qualify if:

  • ASA classification ≥ 3
  • Patient who do not want sedation during the surgery
  • Patient who wants general anesthesia
  • Cardiovascular disease
  • Liver dysfunction
  • Renal dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

OsteoarthritisPain, Postoperative

Interventions

DexmedetomidinePropofol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2016

First Posted

May 27, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)