Intraoperative Sedatives and Postoperative Deilirium

Not Applicable

Completed

• Conditions: Lower Extremity Problem; Delirium; Propofol; Dexmedetomidine
• Interventions: Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT03251651
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-16
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 748

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPF	Propofol	Patient who received propofol during the operation
DEX	Dexmedetomidine	Patient who received dexmedetomidine during the operation

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	Within 3 day postoperatively	The incidence of postoperative delirium

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale	Postoperative 72 hour	Postoperative pain score
Patient controlled analgesia (PCA)	Postoperative 72 hour	Amounts of the PCA consumption
Rescue analgesics	Postoperative 72 hour	Amounts of the analgesics administered to manage the postoperative pain

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of