Intraoperative Sedatives and Postoperative Deilirium

NCT03251651 | Completed

• 1 other identifier: B-1704/391-304
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Problem; Delirium; Propofol; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium

  The incidence of postoperative delirium

  Within 3 day postoperatively

Secondary Outcomes (9)

• Numerical rating scale

  Postoperative 24 hour

• Numerical rating scale

  Postoperative 48 hour

• Numerical rating scale

  Postoperative 72 hour

• Patient controlled analgesia (PCA)

  Postoperative 24 hour

• Patient controlled analgesia (PCA)

  Postoperative 48 hour

Study Arms (2)

PPF

EXPERIMENTAL

Patient who received propofol during the operation

Drug: Propofol

DEX

EXPERIMENTAL

Patient who received dexmedetomidine during the operation

Drug: Dexmedetomidine

Interventions

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.

PPF

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.

DEX

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Delirium

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hyo-Seok Na, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: June 15, 2017
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)