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Completed

NCT Number: NCT03251651

Intraoperative Sedatives and Postoperative Deilirium

Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive, and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is important to promptly manage such behaviors associated with hyperactive delirium. Intraoperative sedation plays an important role in relieving anxiety or stress response of patients. Propofol-a common sedative agent-was reported to cause delirium more frequently, compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU sedation or procedural sedation. However, there has not been any prospective randomized study investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study, based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence of abnormal psycho-motor behavior compared with propofol sedation, investigators prospectively will investigate the incidence of postoperative delirium in elderly patients who undergo orthopedic surgery with regional anesthesia.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 who undergo orthopedic surgery under spinal anesthesia
  • Patients who want to sedation during the surgery
  • Age of 65 years or greater
  • American Society of Anesthesiologists physical status classification 1 and 2

Exclusion criteria

  • General anesthesia
  • Age < 65 years
  • Patients who do not want to sedation during the surgery
  • Patients who do not receive patient controlled analgesia postoperatively.
  • Cognitive disorders
  • Central nervous system disease, including dementia and Parkinson's disease

Treatment and study plan

Propofol

Drug

Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.

Dexmedetomidine

Drug

Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.

Primary outcomes

  1. Postoperative delirium

    Time frame: Within 3 day postoperatively

    The incidence of postoperative delirium

Secondary outcomes

  1. Numerical rating scale

    Time frame: Postoperative 24 hour

    Postoperative pain score

  2. Numerical rating scale

    Time frame: Postoperative 48 hour

    Postoperative pain score

  3. Numerical rating scale

    Time frame: Postoperative 72 hour

    Postoperative pain score

  4. Patient controlled analgesia (PCA)

    Time frame: Postoperative 24 hour

    Amounts of the PCA consumption

  5. Patient controlled analgesia (PCA)

    Time frame: Postoperative 48 hour

    Amounts of the PCA consumption

  6. Patient controlled analgesia (PCA)

    Time frame: Postoperative 72 hour

    Amounts of the PCA consumption

  7. Rescue analgesics

    Time frame: Postoperative 24 hour

    Amounts of the analgesics administered to manage the postoperative pain

  8. Rescue analgesics

    Time frame: postoperative 48 hour

    Amounts of the analgesics administered to manage the postoperative pain

  9. Rescue analgesics

    Time frame: Postoperative 72 hour

    Amounts of the analgesics administered to manage the postoperative pain

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

The Incidence of Postoperative Delirium According to the Different Intraoperative Sedatives, Dexmedetomidine vs. Propofol, in Elderly Patients Undergoing Orthopedic Lower Limb Surgery With Spinal Anesthesia: A Randomized Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2017
Registry last updated
Jul 11, 2022

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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