Record and Analyze the Data of Patient Undergoing Anesthesia for Laparoscopic Cholecystectomy From Patient Monitoring Instruments

NCT03691103 | Unknown

• 1 other identifier: V107C-209
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anesthesia and Analgesia; Laparoscopic Surgical Procedure; Monitoring, Physiologic; Hemodynamic Monitoring; Intraoperative Neurophysiological Monitoring

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

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' surgeons belong to one surgical team to provide consistent laparoscopic cholecystectomy procedures

You may qualify if:

• patients agree and plan to undergo elective laparoscopic cholecystectomy surgery for medical issues such as cholecystitis, gall bladder tumor or gall stone.

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

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (3)

• Lin YT, Wu HT, Tsao J, Yien HW, Hseu SS. Time-varying spectral analysis revealing differential effects of sevoflurane anaesthesia: non-rhythmic-to-rhythmic ratio. Acta Anaesthesiol Scand. 2014 Feb;58(2):157-67. doi: 10.1111/aas.12251.

  PMID: 24410106 BACKGROUND

• Liou JY, Ting CK, Mandell MS, Chang KY, Teng WN, Huang YY, Tsou MY. Predicting the Best Fit: A Comparison of Response Surface Models for Midazolam and Alfentanil Sedation in Procedures With Varying Stimulation. Anesth Analg. 2016 Aug;123(2):299-308. doi: 10.1213/ANE.0000000000001299.

  PMID: 27192475 BACKGROUND

• Li R, Frasch MG, Wu HT. Efficient Fetal-Maternal ECG Signal Separation from Two Channel Maternal Abdominal ECG via Diffusion-Based Channel Selection. Front Physiol. 2017 May 16;8:277. doi: 10.3389/fphys.2017.00277. eCollection 2017.

  PMID: 28559848 BACKGROUND

Related Links

• Data will be uploaded and shared at this website

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

Central Study Contacts

Kuang-Yi Chang, Dr.

CONTACT

+886-938593159; sufentanil@gmail.com

Chien-Kun Ting, Dr.

CONTACT

+886-938593137; 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: August 20, 2018
• First Posted: October 1, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 1, 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 requests will be reviewed by the Institutional Review Board, Taipei Veterans General Hospital, Taiwan. Requestors will be required to sign a Data Access Agreement

Locations

TW (1)