Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

April 8, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

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

  • Name: Sunkyung Park
  • Phone Number: 82-2-2019-4601
  • Email: gsirb@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • GangnamSeverance Hospital
        • Contact:
          • Sunkyung Park
          • Phone Number: 82-2-2019-4601
          • Email: gsirb@yuhs.ac

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

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
Intervention / Treatment
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

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

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)

April 3, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Achalasia

Clinical Trials on Per-oral endoscopic myotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe