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Turkish Precision Anaesthesia Study Project

Turkish Precision Anaesthesia Study Project

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05872529
Acronym
TuPASProject
Enrollment
2200
Registered
2023-05-24
Start date
2023-07-31
Completion date
2025-07-31
Last updated
2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Neurocognitive Disorders

Keywords

Delirium, Neurocognitive Disorders, electroencephalography, Postoperative

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.

Interventions

BEHAVIORALEducation

The education which consists processed EEG monitoring and SBI approach

Sponsors

Ankara University
CollaboratorOTHER
Marmara University
CollaboratorOTHER
Istanbul University - Cerrahpasa
CollaboratorOTHER
Acibadem University
CollaboratorOTHER
Cukurova University
CollaboratorOTHER
Saglik Bilimleri Universitesi
CollaboratorOTHER
Istanbul University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Before and After model

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative deliriumUp to postoperative 3 daysPOD will be assessed by Nu-DESC

Secondary

MeasureTime frameDescription
The incidence of postoperative neurocognitive disorderPostoperative Month 3PND will be assessed by WHODAS2

Other

MeasureTime frameDescription
Duration of recovery room stay24 hoursDuration of recovery room stay will be recorded
Duration of hospital stay2 weeksDuration of hospital stay will be recorded
MortalityPostoperative Month 3Mortality will be recorded

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem Korkmaz Dilmen, Prof
korkmazdilmen@gmail.com00904143000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026