Intraoperative Sedatives and Postoperative Pain

October 25, 2016 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
Patients who received dexmedetomidine during the operation
Drug: Dexmedetomidine
Intraoperative sedation using dexmedetomidine
Experimental: Propofol
Patients who received propofol during the operation
Drug: Propofol
Intraoperative sedation using propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: Postoperative 24 hours
Postoperative pain score at postoperative 24 hours
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue analgesics
Time Frame: Postoperative 24 hours
Amount of rescue analgesics administered during 24 hours postoperatively
Postoperative 24 hours
Rescue analgesics
Time Frame: Postoperative 48 hours
Amount of rescue analgesics administered during 48 hours postoperatively
Postoperative 48 hours
Visual analogue scale
Time Frame: Postoperative 48 hours
Postoperative pain score at postoperative 48 hours
Postoperative 48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea and vomiting
Time Frame: Postoperative 24 hours
Incidence of nausea and vomiting during 24 hours postoperatively
Postoperative 24 hours
Nausea and vomiting
Time Frame: Postoperative 48 hours
Incidence of nausea and vomiting during 48 hours postoperatively
Postoperative 48 hours
Antiemetics
Time Frame: Postoperative 24 hours
Amount of antiemetics administered during 24 hours postoperatively
Postoperative 24 hours
Antiemetics
Time Frame: Postoperative 48 hours
Amount of antiemetics administered during 48 hours postoperatively
Postoperative 48 hours
Patient's satisfaction
Time Frame: Postoperative 48 hours
Patient's satisfaction with the pain management using a visual analogue scale (0 = very unsatisfied, 10 = completely satisfied)
Postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 22, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1603/339-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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