Clinical trial NCT05872529: Turkish Precision Anaesthesia Study Project
Official title: Turkish Precision Anaesthesia Study Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium
Neurocognitive Disorders
Keywords: Delirium
Neurocognitive Disorders
electroencephalography
Postoperative
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Ankara University
name: Marmara University
name: Istanbul University - Cerrahpasa
name: Acibadem University
name: Cukurova University
name: Saglik Bilimleri Universitesi
First posted: 2023-05-24
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before and After model
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: Up to postoperative 3 days
Secondary outcomes:
measure: The incidence of postoperative neurocognitive disorder
timeFrame: Postoperative Month 3
Other outcomes:
measure: Duration of recovery room stay
timeFrame: 24 hours
measure: Duration of hospital stay
timeFrame: 2 weeks
measure: Mortality
timeFrame: Postoperative Month 3
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters
Study officials:
affiliation: Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty
name: Ozlem Korkmaz Dilmen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University, Department of Anesthesiology and Intensive Care
name: Basak Ceyda Meco, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sumner M, Deng C, Evered L, Frampton C, Leslie K, Short T, Campbell D. Processed electroencephalography-guided general anaesthesia to reduce postoperative delirium: a systematic review and meta-analysis. Br J Anaesth. 2023 Feb;130(2):e243-e253. doi: 10.1016/j.bja.2022.01.006. Epub 2022 Feb 17.
citation: Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
citation: Kong H, Xu LM, Wang DX. Perioperative neurocognitive disorders: A narrative review focusing on diagnosis, prevention, and treatment. CNS Neurosci Ther. 2022 Aug;28(8):1147-1167. doi: 10.1111/cns.13873. Epub 2022 Jun 1.
citation: Radtke FM, Franck M, Lendner J, Kruger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.