Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Achalasia

Treatments: Procedure: Per-oral endoscopic myotomy

Study type: Observational

Funder types: Other

Identifiers

NCT05772260

3-2022-0491

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Patients with autonomic dysfunction

Description:

Achalasia patients who have autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.

Treatment:

Procedure: Per-oral endoscopic myotomy

Patients with normal autonomic function

Description:

Achalasia patients without autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.

Treatment:

Procedure: Per-oral endoscopic myotomy