Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

Recruiting

• Conditions: Achalasia
• Interventions: Procedure: Per-oral endoscopic myotomy

• Registration Number: NCT05772260
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Study Start: 2023-04-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with autonomic dysfunction	Per-oral endoscopic myotomy	Achalasia patients who have autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.
Patients with normal autonomic function	Per-oral endoscopic myotomy	Achalasia patients without autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.

Primary Outcome Measures

Name	Time	Method
Wobble of Systolic Arterial Pressure (SAP) during surgery	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

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of