Anesthesia Clinical Trial
Official title:
The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
Precision anesthesia is the current trend. The benefits including faster recovery, earlier return to normal activity, increased patient satisfaction and shorter length of stay. In order to avoid unnecessarily deep or too light anesthesia, processed electroencephalogram (EEG) monitors are applied for accurate assessment of the depth of anesthesia (DoA). Bispectral index (BIS) and PSI monitor are among the most widely used. Recently, density spectral array (DSA) has been developed to facilitate the interpretation of EEG signals. Real-time DSA EEG monitoring helps in detecting even subtle changes in the depth of anesthesia and provides more comprehensive information then simple digits. An emerging field of pharmacodynamics in anesthesia is the response surface models. They describe the interaction of different anesthetics during sedation or anesthesia. Our research team has developed the first comprehensive two-drug response surface models for midazolam and alfentanil during gastrointestinal procedural sedations. However, adequate anesthesia is often achieved with multiple drugs. Two-drug models thus have limited applications. We aim to extend the models into three-drug interactions where it can be used for a broader range of clinical scenarios. The main goal of the study is to establish and validate the three-drug response surface model by collecting and analyzing EEG parameters (BIS or PSI values, DSA, SEF95 (95% spectral edge frequency) and MF (Median frequency) ) from 60 patients undergoing general anesthesia for thoracic surgeries. We aim to establish the models that help anesthesiologist to achieve rapid emergence, appropriate analgesia, adequate DoA, and patient safety. The secondary aim is to apply this model to provide a guideline for drug dosage adjustment and improve the quality of anesthesia.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients aged between 20 and 85 - Scheduled for Non-intubated VATS or VATS surgery depending on study arm. - American Society of Anesthesiologists (ASA) physical status I to III. Exclusion Criteria: - hearing impairment - neurologic or behavioral disorders - habitual sedative use - alcoholism - allergy to dexmedetomidine, alfentanil or propofol - resting room air SpO2 < 90%. - History of upper airway tumors |
Country | Name | City | State |
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Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
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Taipei Veterans General Hospital, Taiwan |
Taiwan,
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Liou JY, Ting CK, Mandell MS, Chang KY, Teng WN, Huang YY, Tsou MY. Predicting the Best Fit: A Comparison of Response Surface Models for Midazolam and Alfentanil Sedation in Procedures With Varying Stimulation. Anesth Analg. 2016 Aug;123(2):299-308. doi: 10.1213/ANE.0000000000001299. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bispectral index (BIS) value or Patient state index (PSI) value | Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. The recorded BIS or PSI value reading is uniform and contains only a unitless number ranging from 0 to 100. Different procedures do not give different units. These values are part of anesthetic depth evaluation and the recordings are aggregated to perform fit in a mathematic model. | EEG are recorded starting from anesthesia induction, and stopped after emergence when surgery ends as a part of routine anesthesia. | |
Primary | EEG frequency | Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. Raw EEG data are recorded and analyzed afterwards. Spectral analysis of the alpha, beta, gamma, theta and delta features will be performed. Individual band powers are summed separately. EEG frequency will be recorded continuously during the total anesthesia time to perform fit in a mathematic model. | EEG are recorded starting from anesthesia induction, and stopped after emergence when surgery ends as a part of routine anesthesia. | |
Primary | Power of the EEG signal | Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. Raw EEG data are recorded and analyzed afterwards. Spectral analysis of the alpha, beta, gamma, theta and delta features will be performed. Individual band powers are summed separately. Power of the EEG signal represents amount of activity in certain frequency bands. Power of the EEG signal will be recorded continuously during the total anesthesia time to perform fit in a mathematic model. | EEG are recorded starting from anesthesia induction, and stopped after emergence when surgery ends as a part of routine anesthesia. | |
Primary | Spectral edge frequency 90 (SEF 90) | Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. Raw EEG data are recorded and analyzed afterwards. Spectral analysis of the alpha, beta, gamma, theta and delta features will be performed. Individual band powers are summed separately. Spectral edge frequency 90 (SEF 90) represents the frequency below which 90 % of the EEG power is located. SEF 90 will be recorded continuously during the total anesthesia time to perform fit in a mathematic model. | EEG are recorded starting from anesthesia induction, and stopped after emergence when surgery ends as a part of routine anesthesia. | |
Primary | Median frequency (MF) | Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. Raw EEG data are recorded and analyzed afterwards. Spectral analysis of the alpha, beta, gamma, theta and delta features will be performed. Individual band powers are summed separately. The median frequency represents the frequency below and above which lies 50% of the total power in the EEG. MF will be recorded continuously during the total anesthesia time to perform fit in a mathematic model. | EEG are recorded starting from anesthesia induction, and stopped after emergence when surgery ends as a part of routine anesthesia | |
Secondary | Modified Observer's Assessment Alertness Scale(MOAA/S) score | Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. MOAA/S is a unitless score between 0 and 5 and is applicable in different anesthesia settings. Different procedures do not give different MOAA/S units. Return of consciousness is defined by a score of MOAA/S greater than 4. The score is a part of anesthetic depth evaluation and the recordings are aggregated to perform fit in a mathematic model. | MOAA/S score will be recorded specifically at induction and emergence phase |
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