Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ankara University | OTHER |
| Marmara University | OTHER |
| Istanbul University - Cerrahpasa | OTHER |
| Acibadem University |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEFORE | No Intervention | The incidence of the POD and PND will determine before the education which consists processed EEG monitoring and SBI approach | |
| AFTER | Active Comparator | The incidence of the POD and PND will determine after the education which consists processed EEG monitoring and SBI approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | The education which consists processed EEG monitoring and SBI approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative delirium | POD will be assessed by Nu-DESC | Up to postoperative 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative neurocognitive disorder | PND will be assessed by WHODAS2 | Postoperative Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of recovery room stay | Duration of recovery room stay will be recorded | 24 hours |
| Duration of hospital stay | Duration of hospital stay will be recorded |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Özlem Korkmaz Dilmen, Prof | Contact | 00904143000 | 63913 | korkmazdilmen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ozlem Korkmaz Dilmen, Prof | Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty | Principal Investigator |
| Basak Ceyda Meco, Prof | Ankara University, Department of Anesthesiology and Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University - Cerrahpasa, Department of Neurosurgery, Neurosurgical Theaters | Istanbul | 34098 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35183345 | Result | 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. | |
| 30336844 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided
| OTHER |
| Cukurova University | OTHER |
| Saglik Bilimleri Universitesi | OTHER |
Before and After model
Not provided
Not provided
Not provided
| 2 weeks |
| Mortality | Mortality will be recorded | Postoperative Month 3 |
| 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. |
| 35652170 | Result | 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. |
| 23539235 | Result | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |