Intraoperative Sedatives and Postoperative Deilirium

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Dexmedetomidine; Propofol; Lower Extremity Problem
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 748
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPF; Patient who received propofol during the operation	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.
Experimental: DEX; Patient who received dexmedetomidine during the operation	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	The incidence of postoperative delirium	Within 3 day postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale	Postoperative pain score	Postoperative 24 hour
Numerical rating scale	Postoperative pain score	Postoperative 48 hour
Numerical rating scale	Postoperative pain score	Postoperative 72 hour
Patient controlled analgesia (PCA)	Amounts of the PCA consumption	Postoperative 24 hour
Patient controlled analgesia (PCA)	Amounts of the PCA consumption	Postoperative 48 hour
Patient controlled analgesia (PCA)	Amounts of the PCA consumption	Postoperative 72 hour
Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	Postoperative 24 hour
Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	postoperative 48 hour
Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	Postoperative 72 hour

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Hyo-Seok Na, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: B-1704/391-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No