Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05688449 |
| Other study ID # |
20220609 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2022 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Bezmialem Vakif University |
| Contact |
mustafa gunay |
| Phone |
+905363146236 |
| Email |
dr.mustafagunay[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
