Analyzing the Noxious Autonomic Response During Shoulder Arthroscope Surgery

• ClinicalTrials.gov Identifier: NCT03688529
• Recruitment Status: Unknown
• First Posted: September 28, 2018
• Last Update Posted: September 28, 2018
• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborator: Duke University
• Information provided by (Responsible Party): Taipei Veterans General Hospital, Taiwan

Tracking Information

• First Submitted Date: September 26, 2018
• First Posted Date: September 28, 2018
• Last Update Posted Date: September 28, 2018
• Estimated Study Start Date: October 2018
• Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 26, 2018)

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".

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analyzing the Noxious Autonomic Response During Shoulder Arthroscope Surgery
• Official Title: Using Physiological Monitoring Instruments to Measure Autonomic Response From Surgical Steps of Shoulder Arthroscopy Surgery
• 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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear

Condition

• Monitoring, Physiologic
• Intraoperative Neurophysiological Monitoring
• Anesthesia and Analgesia
• Arthroscopy

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 26, 2018): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2019
• Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03688529
• Other Study ID Numbers: V107C-209R
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• Study Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Duke University

Investigators

• 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

• PRS Account: Taipei Veterans General Hospital, Taiwan
• Verification Date: September 2018