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Completed

NCT Number: NCT02784626

Intraoperative Sedatives and Postoperative Pain

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.

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Key information

Conditions

Arthritis, Degenerative Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Intraoperative sedation using dexmedetomidine

Propofol

Drug

Intraoperative sedation using propofol

Primary outcomes

  1. Visual analogue scale

    Time frame: Postoperative 24 hours

    Postoperative pain score at postoperative 24 hours

Secondary outcomes

  1. Rescue analgesics

    Time frame: Postoperative 24 hours

    Amount of rescue analgesics administered during 24 hours postoperatively

  2. Rescue analgesics

    Time frame: Postoperative 48 hours

    Amount of rescue analgesics administered during 48 hours postoperatively

  3. Visual analogue scale

    Time frame: Postoperative 48 hours

    Postoperative pain score at postoperative 48 hours

Other outcomes

  1. Nausea and vomiting

    Time frame: Postoperative 24 hours

    Incidence of nausea and vomiting during 24 hours postoperatively

  2. Nausea and vomiting

    Time frame: Postoperative 48 hours

    Incidence of nausea and vomiting during 48 hours postoperatively

  3. Antiemetics

    Time frame: Postoperative 24 hours

    Amount of antiemetics administered during 24 hours postoperatively

  4. Antiemetics

    Time frame: Postoperative 48 hours

    Amount of antiemetics administered during 48 hours postoperatively

  5. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 27, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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