Clinical Trials Logo

Clinical Trial Summary

It has been shown in previous studies that burst suppression has an effect on the development of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). With the development of technology, EEG-based anesthesia management is getting more and more attention. In particular, methods that reduce anesthetic drug consumption are expected to prevent POD and POCD by reducing burst suppression. There are studies that show that epidural analgesia applications reduce general anesthesia drug consumption in patients receiving general anesthesia. In this study, investigators want to investigate the effect of epidural analgesia combined with general anesthesia on burst suppression. POD and POCD development in these patients will be examined as secondary objectives.


Clinical Trial Description

Postoperative delirium (POD) is an acute cognitive disorder characterized by inattention, disorganized thinking, and a fluctuating course that develops over hours or days. Although delirium depends on the type of surgery, it is a common postoperative complication with an incidence of 10%-70%. POD causes an increase in mortality, morbidity and health care costs. Risk factors for POD; age, type and duration of surgery, inadequate pain control, type of anesthesia, anemia, transfusion, and preoperative cognitive impairment. In recent years, it has been emphasized that POD can be reduced with the widespread use of electroencephalogram (EEG) based anesthesia management and optimization of anesthetic drugs according to EEG patterns. EEG consists of 6 waveforms: slow, delta, theta, alpha, beta and gamma. Behavioral and neurophysiological patterns caused by anesthetic drugs are associated with different electroencephalogram waveforms. Recent developments in the introduction of EEG-based monitors have made significant contributions to the understanding of the fundamental changes in brain activity caused by anesthetic agents. Today, there are EEG-based anesthesia depth monitors such as bispectral index (BIS) (Medtronic, USA) or Sedline (Masimo Irvine CA). These monitors make it easier to optimize the depth of anesthesia with the numerical data obtained as a result of some calculations as well as the raw EEG. The burst suppression (BS) pattern on the EEG shows a decrease in brain neuronal activity and metabolic activity. Burst suppression can be induced by anesthetic drugs that modulate γ-aminobutyric acid type A receptors. Although sometimes deliberately induced for therapeutic purposes to treat refractory status epilepticus or increased intracranial pressure, burst suppression is generally considered potentially harmful and should be avoided.Studies conducted in recent years have shown the relationship between intraoperative burst suppression (BS) and POD. POD; It can be reduced by continuous EEG monitoring, reducing the dose of propofol, preferring regional anesthesia, effective postoperative pain control, early mobilization, and early postoperative discharge. Interventions that can reduce the development of postoperative delirium will be important for public health. Epidural analgesia can be used effectively in perioperative analgesia. It has been reported in the literature that epidural analgesia combined with general anesthesia reduces the amount of hypnotic drug required to achieve similar depth of anesthesia compared to general anesthesia alone. There is no study in the literature on whether the combination of epidural analgesia and general anesthesia reduces BS in EEG-based anesthesia applications. Our primary aim in this study is to evaluate whether the combination of general anesthesia and epidural analgesia reduces BS in EEG-based anesthesia in patients undergoing total hip and knee arthroplasty. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05688449
Study type Interventional
Source Bezmialem Vakif University
Contact mustafa gunay
Phone +905363146236
Email dr.mustafagunay@gmail.com
Status Recruiting
Phase Phase 4
Start date July 30, 2022
Completion date April 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05273125 - MOBility Disorders Assessment in Patients With Mild COGnitive Disorders
Active, not recruiting NCT04049695 - Improving Cognition After Cancer N/A
Completed NCT05912374 - Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs N/A
Recruiting NCT03977350 - Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
Not yet recruiting NCT06027632 - Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer N/A
Terminated NCT00754013 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Phase 3
Terminated NCT00754052 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Phase 3
Completed NCT00719628 - Depth of Anaesthesia and Cognitive Dysfunction N/A
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Completed NCT04966455 - Effect of Raisins on Cognitive Function in Healthy Older Adults Phase 3
Recruiting NCT05372159 - Vanderbilt Memory and Aging Project
Completed NCT03243279 - BRS and Outcomes in Cardiothoracic Surgery
Completed NCT04093882 - The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
Recruiting NCT05732285 - A Pilot Randomized Controlled Trial: CoINTEGRATE N/A
Completed NCT06059768 - Urdu Translation and Psychometric Analysis of Lawton IADLS.
Completed NCT04624529 - Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke
Completed NCT04562662 - Evaluation of mediVR-KAGURA Guided Therapy N/A
Not yet recruiting NCT04079075 - Multiple Interventions to Prevent Cognitive Decline N/A
Active, not recruiting NCT04638101 - Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention N/A
Active, not recruiting NCT04556305 - Lifestyle Physical Activity and Cognitive Training Interventions N/A