Analyzing the Noxious Autonomic Response During Shoulder Arthroscope Surgery

NCT03688529 | Unknown

• 1 other identifier: V107C-209R
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (1)

• Pharmacological modeling of epidemiological factors and anesthetic factors to physiological data from patient monitoring instrument

  The intra-operative period which mostly lasts less than two hours, the duration of general anesthesia

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Duke University: collaborator

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Kun Ting, Dr.

  Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

• Shen-Chih Wang

  Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Yi Chang, Dr.

CONTACT

0938593159; sufentanil@gmail.com

Chien-Kun Ting, Dr.

CONTACT

0938593137; ckting@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.