Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04539080
Collaborator
(none)
50
1
36
1.4

Study Details

Study Description

Brief Summary

Heart rate variability(HRV) and electroencephalography(EEG) has been used widely in anesthetic practice nowadays. One of the most dominant applications is the nociception-analgesia balance. Some evidence support that heart rate variability correlates with perioperative stimulation and postoperative pain score. There are some new evidence support EEG correlated with anesthesia depth and analgesic balance. However, the heterogeneity between the studies and interference factors has limited their usage in clinical practice. On the other hand, peripheral nerve block is broadly used as a routine technique with general anesthesia, but few studies discuss the effect on heart rate variability. Our study focuses on the different HRV and EEG patterns of incision and insufflation during laparoscopic surgery with general anesthesia. Furthermore, we measure the effect of transversus abdominis plane nerve block to heart rate variability during surgery. By this comparison, we can discuss the influences of somatic stimulation, visceral stimulation, and pneumoperitoneum to heart rate variability, and then improve the accuracy of HRV-based nociception-analgesia monitors.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transversus abdominis plane block

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Heart Rate Variability and Electroencephalography Analysis in Laparoscopic Surgery With or Without Transversus Abdominis Plane Block
Actual Study Start Date :
Aug 30, 2020
Actual Primary Completion Date :
Feb 28, 2021
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Pre-operative transversus abdominis plane block

Procedure: transversus abdominis plane block
transversus abdominis plane block before or after laparoscopy operation

Post-operative transversus abdominis plane block

Procedure: transversus abdominis plane block
transversus abdominis plane block before or after laparoscopy operation

Outcome Measures

Primary Outcome Measures

  1. Different heart rate variability pattern during laparoscopy [6 months]

    Different heart rate variability pattern in incision and inflation with or without TAP block

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • ≥18 years of age male or female

  • American Society of Anesthesiologists (ASA) physical status classification I or II

  • capacity to give informed consent

Exclusion Criteria:
  • major cardiovascular and cerebral vascular disease, arrhythmia, respiratory disease, diabetes mellitus with evidence of neuropathy; ASA physical status classification III or greater; a documented or self-reported history of chronic pain; acute or chronic opioid analgesic use; dysautonomia; and intraoperative muscarinic anticholinergic administration during the time of monitoring.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taitung MacKay memorial hospital Taitung Taitung, Taiwan Taiwan

Sponsors and Collaborators

  • Mackay Memorial Hospital

Investigators

  • Principal Investigator: Tzu-Chun Wang, MD, Taitung Mackay Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04539080
Other Study ID Numbers:
  • 20MMHIS210e
First Posted:
Sep 4, 2020
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2022