NCT Number: NCT06844279
This study will be conducted on patients aged 65 and older scheduled for surgery due to lumbar or cervical disc herniation. General anesthesia is routinely used for these types of surgeries in the hospital. In patients receiving general anesthesia, anesthesia depth monitoring is performed.
As part of the study, a preoperative anesthesia evaluation will be conducted, which will include age, weight, height, comorbidities, regularly used medications, previous surgical or anesthesia experiences, nutritional habits, mental status, and daily activity levels.
On the day of surgery, upon arrival in the operating room, the following will be measured and recorded:
* Blood pressure using a non-invasive blood pressure monitor * Heart rate and rhythm via electrocardiogram (ECG) * Blood oxygen level with a pulse oximeter * Anesthesia depth using a forehead-applied sensor
All monitoring procedures are non-invasive and painless. Following the placement of these monitoring devices and initial measurements, anesthesia induction and surgery will commence. Throughout surgery, blood pressure, heart rate, and brain activity will be continuously recorded. After the surgical procedure, anesthesia emergence and mental status will be assessed. Preoperative evaluation data and intraoperative recordings will be used solely for research purposes, with patient identity information remaining confidential.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Ankara, 06560, Turkey (Türkiye)
Location status: Recruiting
Aslihan Gulec Kilic, MD
CONTACT
Aslihan Gulec Kilic, MD
SUB_INVESTIGATOR
Gozde Inan, Associate Professor
CONTACT
Gozde Inan, Associate Professor
SUB_INVESTIGATOR
Zerrin Ozkose Satirlar, Professor
PRINCIPAL_INVESTIGATOR
Perioperative cognitive decline and delirium occur more frequently in the geriatric population undergoing surgery. International guidelines recommend monitoring anesthesia depth to reduce the risk of postoperative cognitive dysfunction. Anesthesia depth is commonly measured using non-invasive electroencephalography (EEG)-based methods, such as the Bispectral Index (BIS).
Previous studies have predominantly utilized processed EEG monitors that generate numerical values for tracking anesthesia depth. However, in this study, anesthesia depth will be monitored using both the standard numerical BIS index and the Density Spectral Array (DSA) mode, an advanced feature of the BIS device. To date, no studies have simultaneously examined BIS and DSA modes in relation to cognitive function and the recovery process.
The use of advanced monitoring techniques may serve as a valuable resource for future research, particularly in optimizing anesthetic management for geriatric patients with reduced cognitive reserve. This study aims to evaluate the effects of different intraoperative anesthesia depth monitoring approaches, including hemodynamic monitoring, numerical BIS values, and DSA functions. The primary objective is to determine the optimal anesthesia monitoring strategy that minimizes intraoperative hypotension, burst suppression, and postoperative delirium.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anesthesia depth monitoring based on hemodynamic values without additional processed EEG guidance.
Anaesthesia depth monitoring according to numeric BIS index values.
Anaesthesia depth monitoring according to density spectral array functions
Time frame: Intraoperative (continuously recorded from anesthesia induction to emergence)
The burst suppression ratio (BSR) will be calculated as the percentage of total anesthesia time spent in burst suppression, as measured by processed electroencephalography (EEG). A higher BSR has been associated with worse postoperative cognitive outcomes.
Time frame: Intraoperative (continuously recorded from anesthesia induction to emergence)
Anesthesia time spent in burst suppression (BS), as measured by processed electroencephalography (EEG). A higher BS time has been associated with worse postoperative cognitive outcomes.
Time frame: Intraoperative (assessed continuously throughout surgery)
Intraoperative hypotension will be measured in 5-minute intervals. Hypotension is a mean arterial pressure (MAP) below 60 mmHg. The episodes of hypotension at any point during surgery will be recorded.
Time frame: Intraoperative (measured continuously from anesthesia induction to emergence)
Alpha band activity (8-12 Hz) in the frontal lobe will be evaluated to determine whether it is preserved or lost during general anesthesia. Alpha band preservation is associated with optimal anesthesia depth and cognitive function preservation, while loss of alpha band activity is linked to increased postoperative cognitive impairment.
Time frame: Postoperative (assessed at 6, 24, and 48 hours after surgery)
Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) tool. The number of participants meeting the criteria for delirium within the first 48 hours postoperatively will be recorded.
Time frame: Intraoperative
The total dose of propofol administered intraoperatively will be recorded. Data will be reported as mg/kg.
Time frame: Intraoperative
The total dose of Sevoflurane administered intraoperatively will be recorded. Data will be reported as ml.
Time frame: Intraoperative
The total dose of Remifentanil administered intraoperatively will be recorded. Data will be reported as mcg/kg.
Time frame: Intraoperative
The total dose of vasopressors (noradrenaline, adrenaline, dopamine) administered intraoperatively will be recorded. Data will be reported as mcg/kg.
Time frame: Preoperative (assessed on the day of surgery)
Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 (very fit) to 9 (terminally ill). Higher scores indicate worse frailty status. The proportion of participants classified as frail (CFS ≥ 5) will be reported.
Contact information is provided by the study sponsor or research team.
Aslihan Gulec Kilic, MD
CONTACT
Gozde Inan, Associate Professor
CONTACT
Aslıhan Güleç
Other
Geriatrik Hasta Grubunda Anestezi Derinliği Monitörizasyonlarının Postoperatif Derlenme ve Bilişsel Fonksiyonlara Etkileri
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07266727
Confusion, Delirium
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06892769
Geriatric Patient Care Improvement
View Trial DetailsNCT01351441
Behavior, Geriatric Patient Care Improvement
Cheektowaga, New York, United States
View Trial DetailsNCT07357480
Burst Suppression, Confusion
Istanbul, Bakırköy, Turkey (Türkiye)
View Trial Details