Analyzing the Noxious Autonomic Response During Shoulder Arthroscope Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03688529|
Recruitment Status : Unknown
Verified September 2018 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was: Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
|Condition or disease|
|Monitoring, Physiologic Intraoperative Neurophysiological Monitoring Anesthesia and Analgesia Arthroscopy|
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 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, skin incision, dissecting muscle layer, fixing rupture site, suture to close tear site and wound closure. 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Using Physiological Monitoring Instruments to Measure Autonomic Response From Surgical Steps of Shoulder Arthroscopy Surgery|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
- 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 [ Time Frame: For each surgical events (skin incision, dissection... ), time frame will be one minute before the event to one minute afterward ]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.
- Pharmacological modeling of epidemiological factors and anesthetic factors to physiological data from patient monitoring instrument [ Time Frame: The intra-operative period which mostly lasts less than two hours, the duration of general anesthesia ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688529
|Contact: Kuang-Yi Chang, Dr.||firstname.lastname@example.org|
|Contact: Chien-Kun Ting, Dr.||email@example.com|
|Study Director:||Chien-Kun Ting, Dr.||Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan|
|Principal Investigator:||Shen-Chih Wang||Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan|