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Clinical Trials/NCT05872529
NCT05872529
Not yet recruiting
Not Applicable

Turkish Precision Anaesthesia Study Project

Istanbul University1 site in 1 country2,200 target enrollmentJuly 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Istanbul University
Enrollment
2200
Locations
1
Primary Endpoint
The incidence of postoperative delirium
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Postoperative delirium (POD) and postoperative neurocognitive disorder (PND) increase the length of hospital stay, morbidity and mortality, especially in elderly patients. Although several risk factors were determined and incidence trials were performed on the development of POD and PND, there has not yet been a multicentre, large-participant study in Turkish population. The SBI approach monitor, detect and help physicians and all perioperative team members to decrease and avoid the adverse side effects of surgery and anaesthesia. In this "before and after" design trial the incidence of POD and PND will be compared before and after education which consists processed EEG and SBI approach.

The primary aim of the study is to determine the effect of education which consists processed EEG monitoring and regularly assessment of patient's stress, anxiety, pain, nausea, vomiting, thirst, hunger and better communication at the pre- and postoperative period on the incidence of POD. The secondary aim of the study is to assess the effect of the Safe Brain Initiative approach on patients' thirst feeling, stress-anxiety levels, postoperative pain, postoperative nausea and vomiting, well-being, satisfaction, length of PACU or recovery room stay, length of hospital stay, incidence of PND and in hospital and 3-month mortality. Also, the physicians', nurses' and patients satisfaction will be assessed.

Detailed Description

Postoperative delirium (POD) and postoperative neurocognitive disorder (PND) increase the length of hospital stay, morbidity and mortality, especially in elderly patients. Although several risk factors were determined and incidence trials were performed on the development of POD and PND, there has not yet been a multicentre, large-participant study in Turkish population. The EJA guideline recommends depth of anaesthesia monitoring, especially in frail patients since intraoperative burst suppression increases the risk of PND. American guideline emphasizes that the effect of processed EEG monitoring on POD cannot be fully demonstrated, but it may reduce PND. Yet, processed EEG monitors, when simplified to an index number, may not accurately reflect the depth of anaesthesia. To detect vulnerable patients, EEG training can be easily implemented. Thus, the incidence of POD and PND may decrease. Additionally, not just EEG monitoring but also regular assessment of patients' stress, anxiety, pain, nausea, vomiting, thirst, and hunger during the pre-and postoperative period and better communication with the patients would reduce the risk of POD. That's why we will use the Safe Brain Initiative (SBI) approach. The SBI approach monitor, detect and help physicians and all perioperative team members to decrease and avoid the adverse side effects of surgery and anaesthesia. In this "before and after" design trial the incidence of POD and PND will be compared before and after education which consists processed EEG and SBI approach. The primary aim of the study is to determine the effect of education which consists processed EEG monitoring and regularly assessment of patient's stress, anxiety, pain, nausea, vomiting, thirst, hunger and better communication at the pre- and postoperative period on the incidence of POD. The secondary aim of the study is to assess the effect of the Safe Brain Initiative approach on patients' thirst feeling, stress-anxiety levels, postoperative pain, postoperative nausea and vomiting, well-being, satisfaction, length of PACU or recovery room stay, length of hospital stay, incidence of PND and in hospital and 3-month mortality. Also, the physicians', nurses' and patients satisfaction will be assessed.

Registry
clinicaltrials.gov
Start Date
July 2023
End Date
July 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Özlem Korkmaz Dilmen

Prof MD

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Patients over 18 years of age
  • Patients who will scheduled for non-cardiac, non-cranial surgery under general anaesthesia
  • Patients who will undergo intraoperative processed EEG monitoring

Exclusion Criteria

  • Patients who will undergo outpatient, cardiac or intracranial surgery
  • Patients undergoing surgery with regional anesthesia
  • Alzheimer disease
  • Psychiatric disorder
  • Using antipsychotic drug
  • Who will refuse to participate in study w
  • Who scheduled for a second surgery within 3 months
  • Who admitted to the ICU postoperatively with intubated and sedated

Outcomes

Primary Outcomes

The incidence of postoperative delirium

Time Frame: Up to postoperative 3 days

POD will be assessed by Nu-DESC

Secondary Outcomes

  • The incidence of postoperative neurocognitive disorder(Postoperative Month 3)

Study Sites (1)

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