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Intraoperative Sedatives and Postoperative Pain

Primary Purpose

Arthritis, Degenerative

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis, Degenerative focused on measuring Dexmedetomidine, Propofol, Pain, Postoperative

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dexmedetomidine

Propofol

Arm Description

Patients who received dexmedetomidine during the operation

Patients who received propofol during the operation

Outcomes

Primary Outcome Measures

Visual analogue scale
Postoperative pain score at postoperative 24 hours

Secondary Outcome Measures

Rescue analgesics
Amount of rescue analgesics administered during 24 hours postoperatively
Rescue analgesics
Amount of rescue analgesics administered during 48 hours postoperatively
Visual analogue scale
Postoperative pain score at postoperative 48 hours

Full Information

First Posted
May 22, 2016
Last Updated
October 25, 2016
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02784626
Brief Title
Intraoperative Sedatives and Postoperative Pain
Official Title
The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Degenerative
Keywords
Dexmedetomidine, Propofol, Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Patients who received dexmedetomidine during the operation
Arm Title
Propofol
Arm Type
Experimental
Arm Description
Patients who received propofol during the operation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Intraoperative sedation using dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Intraoperative sedation using propofol
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Postoperative pain score at postoperative 24 hours
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Rescue analgesics
Description
Amount of rescue analgesics administered during 24 hours postoperatively
Time Frame
Postoperative 24 hours
Title
Rescue analgesics
Description
Amount of rescue analgesics administered during 48 hours postoperatively
Time Frame
Postoperative 48 hours
Title
Visual analogue scale
Description
Postoperative pain score at postoperative 48 hours
Time Frame
Postoperative 48 hours
Other Pre-specified Outcome Measures:
Title
Nausea and vomiting
Description
Incidence of nausea and vomiting during 24 hours postoperatively
Time Frame
Postoperative 24 hours
Title
Nausea and vomiting
Description
Incidence of nausea and vomiting during 48 hours postoperatively
Time Frame
Postoperative 48 hours
Title
Antiemetics
Description
Amount of antiemetics administered during 24 hours postoperatively
Time Frame
Postoperative 24 hours
Title
Antiemetics
Description
Amount of antiemetics administered during 48 hours postoperatively
Time Frame
Postoperative 48 hours
Title
Patient's satisfaction
Description
Patient's satisfaction with the pain management using a visual analogue scale (0 = very unsatisfied, 10 = completely satisfied)
Time Frame
Postoperative 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing total knee arthroplasty Age: 20 - 80 yrs Exclusion Criteria: ASA classification ≥ 3 Patient who do not want sedation during the surgery Patient who wants general anesthesia Cardiovascular disease Liver dysfunction Renal dysfunction
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Sedatives and Postoperative Pain

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