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

NCT ID: NCT04539080

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-30

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autonomic Nervous System Nerve Block Laparoscopy Anesthesia and Analgesia EEG

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-operative transversus abdominis plane block

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

transversus abdominis plane block

Intervention Type PROCEDURE

transversus abdominis plane block group

Traditional pain control group

The group with a standard pain control protocol

No interventions assigned to this group

Interventions

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transversus abdominis plane block

transversus abdominis plane block group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ≥20 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tzu-Chun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Taitung Mackay Memorial Hospital

Locations

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Taitung MacKay memorial hospital

Taitung, Taitung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tzu-Chun Wang, MD

Role: CONTACT

+886-02-2543-3535

Facility Contacts

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Tzu-Chun Wang, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37428681 (View on PubMed)

Other Identifiers

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20MMHIS210e

Identifier Type: -

Identifier Source: org_study_id

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