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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
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
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Brief Summary:
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 shoulder arthroscopic surgery. 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.

Condition or disease
Monitoring, Physiologic Intraoperative Neurophysiological Monitoring Anesthesia and Analgesia Arthroscopy

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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".


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear
Criteria

Inclusion Criteria:

  • patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Kuang-Yi Chang, Dr. 0938593159 sufentanil@gmail.com
Contact: Chien-Kun Ting, Dr. 0938593137 ckting@vghtpe.gov.tw

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Duke University
Investigators
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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
More Information
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03688529    
Other Study ID Numbers: V107C-209R
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome will be made available at Dataverse. (https://dataverse.harvard.edu/)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access will be under the term of use of Dataverse website.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No