Hemodynamic Monitoring Clinical Trial
Official title:
To Record and Analyze the Physiological Data From Anesthetic Monitoring Instruments Regarding Cardiovascular, Neurological System, and Surgical Stress for Patients Undergoing Laparoscopic Cholecystectomy in a Stepwise Approach.
To record the digital data from monitoring instruments (standard patient monitor) containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index, Analgesia Nociception Index) containing neurological system information captured in the patient monitor, as well as the physiological data regarding anesthetic dosage, respiratory gas analysis and the standard monitoring requirement of anesthesia. The investigators also record the precise time points of detail surgical steps during the laparoscopic cholecystectomy. Clinical data collected from these monitoring instrument will be used to gain more understanding of the complex interaction between anesthetic effect, surgical procedure, autonomic response and drug modeling. The goal is to obtain the performance of each monitoring index in detail surgical steps.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | November 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - patients agree and plan to undergo elective laparoscopic cholecystectomy surgery for medical issues such as cholecystitis, gall bladder tumor or gall stone. Exclusion Criteria: - major cardiac problems - uncontrolled hypertension - arrhythmia shown in pre-operative ECG - major neurological disease - vulnerable populations per institutional regulation, including under-age, history of drug abuse, HIV carrier, AIDS, aborigine, prisoner. - anticipated difficult airways |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Anesthesiology, Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan | Duke University |
Taiwan,
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Lin YT, Wu HT, Tsao J, Yien HW, Hseu SS. Time-varying spectral analysis revealing differential effects of sevoflurane anaesthesia: non-rhythmic-to-rhythmic ratio. Acta Anaesthesiol Scand. 2014 Feb;58(2):157-67. doi: 10.1111/aas.12251. — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of the instantaneous effects and accumulative noxious effects of surgical steps with quantitative transient bradycardia indices: high frequency power, low frequency power, and the low-to-high ratio | Frequency power will be calculated using time-frequency analysis technique. The unit of high frequency power and low frequency power is millisecond square. There is no unit for the ratio. Both absolute change and relative change will be calculated. These indices will be compared with physiological data from patient monitoring instrument also. Range of Spearman correlation is -1 to 1 and Range of prediction probability is 0.5-1. | For each surgical events (skin incision, dissection... ), time frame will be one minute before the event to one minute afterward | |
Secondary | Pharmacological modeling of epidemiological factors and anesthetic factors to physiological data from patient monitoring instrument | The effects of age, gender, pre-existing diseases, the effect site concentration of anesthetics and the combined effects are taken into consideration in real-life clinical anesthetic management. The collected data will be put altogether for analysis by training and verifying in a pharmacological drug surface modeling or other more advanced modeling tools, which include but not limited to "Concentration-effect curve", "Reduced Greco model", "Minto model" and "Hierarchy model". | The intra-operative period which mostly lasts less than two hours |
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