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.
The dynamic interaction between surgery and anesthesia is closely monitored by the
anesthesiologist using various monitoring instruments in the operating room. However, it
requires the recording and collecting the data for further analysis to answer the question
that what is the exact effects of the surgical procedure to human body. In particular, the
measurement performance of transient bradycardia calculated from electrocardiography and the
monitoring indices such as Surgical Plethysmography Index, Analgesia Nociception Index should
be compared side-by-side using data from the same subject.
In this prospective observational study, the investigators will enroll 40 patients undergoing
elective laparoscopic surgery. Anesthetic management and surgery will be performed as usual
clinical practice.
The investigators will record the digital data exported from monitoring instruments,
including cardiovascular system information (electrocardiography, photo-plethysmography ,
blood pressure and any additional monitoring items clinically required), neurological system
information (Bispectral index, Entropy, Surgical Plethysmography Index ) and the respiratory
gas monitoring (gas analyzer, respiratory waveform). All above data are provided by standard
patient monitor (CARESCAPE Monitor B850, GE Healthcare). Analgesia Nociception Index are
provides by Analgesia Nociception Index monitoring instruments (Mdoloris(TM) Medical
Systems).
The detailed surgical steps will be noted with precise time stamps to pinpoint the surgical
effects afterwards. Registered events including anesthetic induction, intubation,
disinfection, each skin incision, peritoneum perforation, laparoscopic trocar insertion,
dissection, ligation and excision of cystic duct and vessel, electrocauterization, and
extraction of specimen. The recording is ended before the end of monitoring in the operating
room. All physiological data and demographic data will be stored in digital media after being
de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the temporal effect
and relationship. Methods including modeling, windowing and non-parametric spectral
estimation will be used.
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