Intraoperative Sedatives and Postoperative Deilirium

Delirium Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251651
• Other study ID #: B-1704/391-304
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: October 15, 2021

Study information

• Verified date: July 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Dexmedetomidine
• Lower Extremity Problem
• Propofol

Intervention

Drug:
• Propofol
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
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium	The incidence of postoperative delirium	Within 3 day postoperatively
Secondary	Numerical rating scale	Postoperative pain score	Postoperative 24 hour
Secondary	Numerical rating scale	Postoperative pain score	Postoperative 48 hour
Secondary	Numerical rating scale	Postoperative pain score	Postoperative 72 hour
Secondary	Patient controlled analgesia (PCA)	Amounts of the PCA consumption	Postoperative 24 hour
Secondary	Patient controlled analgesia (PCA)	Amounts of the PCA consumption	Postoperative 48 hour
Secondary	Patient controlled analgesia (PCA)	Amounts of the PCA consumption	Postoperative 72 hour
Secondary	Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	Postoperative 24 hour
Secondary	Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	postoperative 48 hour
Secondary	Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	Postoperative 72 hour