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

NCT04539080 | Unknown

• 1 other identifier: 20MMHIS210e
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Nervous System; Nerve Block; Laparoscopy; Anesthesia and Analgesia; EEG

Outcome Measures

Primary Outcomes (1)

• Different heart rate variability pattern during laparoscopy

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

  6 months

Study Arms (2)

Pre-operative transversus abdominis plane block

The group with transversus abdominis plane block before laparoscopic surgeries with a standard pain control protocol

Procedure: transversus abdominis plane block

Traditional pain control group

The group with a standard pain control protocol

Interventions

transversus abdominis plane block PROCEDURE

transversus abdominis plane block group

Pre-operative transversus abdominis plane block

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

scheduled to undergo general anesthesia for laparoscopic surgery (cholecystectomy or appendectomy) at Taitung MacKay memorial hospital

You may qualify if:

• ≥20 years of age male or female
• American Society of Anesthesiologists (ASA) physical status classification I or II
• capacity to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Taitung MacKay memorial hospital

Taitung, Taitung, Taiwan, Taiwan

RECRUITING

Related Publications (1)

• Wang TC, Li WY, Lai JC, Kuo TBJ, Yang CCH. Nociception Effect on Frontal Electroencephalogram Waveform and Phase-Amplitude Coupling in Laparoscopic Surgery. Anesth Analg. 2024 May 1;138(5):1070-1080. doi: 10.1213/ANE.0000000000006609. Epub 2023 Jul 10.

  PMID: 37428681 DERIVED

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

• Tzu-Chun Wang, MD

  Taitung Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Chun Wang, MD

CONTACT

+886-02-2543-3535; ff_west@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: August 30, 2020
• Primary Completion: February 28, 2021
• Study Completion: August 30, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)