Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

July 21, 2026 updated by: Dong Woo Han, Gangnam Severance Hospital

Effect of Autonomic Dysfunction on Hemodynamic Instability During Per-oral Endoscopic Myotomy in Achalasia Patients: a Prospective Observational Study

This prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. Per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. During per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic CO2 accumulation can potentially impair hemodynamics. Moreover, it has been suggested that achalasia is associated with autonomic dysfunction. We hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. In this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using EV1000 clinical platform (Edwards Lifesciences, USA) during surgery. The association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sunkyung Park
  • Phone Number: 82-2-2019-4601
  • Email: gsirb@yuhs.ac

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea
        • GangnamSeverance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital will be eligible.

Description

Inclusion Criteria:

  1. Patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital
  2. Patients aged ≥ 19 years

Exclusion Criteria:

  1. Patients who are hemodynamically unstable before surgery
  2. Patients in whom preoperative heart rate variability (HRV) test cannot be conducted
  3. Pregnant women of breastfeeding women
  4. Patients unable to read the informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with autonomic dysfunction
Achalasia patients who have autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.
Procedure: Per-oral endoscopic myotomy

Per-oral endoscopic myotomy will be performed under general anesthesia. Per-oral endoscopic myotomy will be performed according to the standard care.

General anesthesia will be conducted according to the standard care in our institution, and standardized as follows.

  • Monitoring: ECG, SpO2, noninvasive blood pressure, invasive blood pressure monitoring via radial artery cannulation, advanced hemodynamic monitoring (including cardiac output, cardiac index) uisng EV1000 clinical platform (Edwards Lifesciences, USA), anesthetic depth monitoring by SedLine Sedation monitor (Masimo corporation).
  • Anesthetic induction: Target controlled infusion (TCI) of Remifentanil (target 3.0 ng/mL), propofol 2 mg/kg IV, rocuronium 0.8 mg/kg IV
  • Anesthetic maintence: sevoflurane 0.9 age corrected MAC and remifentanil TCI (target range 1.0-4.0 ng/mL)
Other Names:
  • general anesthesia
Patients with normal autonomic function
Achalasia patients without autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.
Procedure: Per-oral endoscopic myotomy

Per-oral endoscopic myotomy will be performed under general anesthesia. Per-oral endoscopic myotomy will be performed according to the standard care.

General anesthesia will be conducted according to the standard care in our institution, and standardized as follows.

  • Monitoring: ECG, SpO2, noninvasive blood pressure, invasive blood pressure monitoring via radial artery cannulation, advanced hemodynamic monitoring (including cardiac output, cardiac index) uisng EV1000 clinical platform (Edwards Lifesciences, USA), anesthetic depth monitoring by SedLine Sedation monitor (Masimo corporation).
  • Anesthetic induction: Target controlled infusion (TCI) of Remifentanil (target 3.0 ng/mL), propofol 2 mg/kg IV, rocuronium 0.8 mg/kg IV
  • Anesthetic maintence: sevoflurane 0.9 age corrected MAC and remifentanil TCI (target range 1.0-4.0 ng/mL)
Other Names:
  • general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wobble of Systolic Arterial Pressure (SAP) during surgery
Time Frame: During the intraoperative period, from the enterance to the operating room to the emergence of anesthesia
Wobble of SAP will be calculated according to the following formula. Performance Error (PE (%)) = (measured SAP-reference SAP) × 100/reference SAP Median performance error (MDPE (%)) = median {PEi, i = 1, 2, 3…, N} Median absolute performance error (MDAPE (%)) = median {|PE| , i = 1, 2, 3…, N} (N, number of measured SAP) Wobble (%) = median{|MDPE - PEi|, i = 1, 2, 3…, N}(N, number of measured PE) reference SAP = 120 mmHg
During the intraoperative period, from the enterance to the operating room to the emergence of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gangnam Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3-2022-0491

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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