Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772260
• Other study ID #: 3-2022-0491
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Gangnam Severance Hospital
• Contact: sunkyung Park
• Phone: 82-2-2019-4601
• Email: gsirb[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Autonomic Nervous System Diseases
• Esophageal Achalasia
• Primary Dysautonomias

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Saugel B, Vokuhl C, Pinnschmidt HO, Rosch T, Petzoldt M, Loser B. Cardiovascular dynamics during peroral endoscopic myotomy for esophageal achalasia: a prospective observational study using non-invasive finger cuff-derived pulse wave analysis. J Clin Monit Comput. 2021 Aug;35(4):827-834. doi: 10.1007/s10877-020-00541-8. Epub 2020 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wobble of Systolic Arterial Pressure (SAP) during surgery	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