Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Per-oral Endoscopic Myotomy

Procedure

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Mar 16, 2023
Registry last updated: Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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