Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

NCT05772260 | Recruiting

• 1 other identifier: 3-2022-0491
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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)

Also known as: general anesthesia

Patients with autonomic dysfunction; Patients with normal autonomic function

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital will be eligible.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Related 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.

  PMID: 32504156 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

sunkyung Park

CONTACT

82-2-2019-4601; gsirb@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: April 3, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

KR (1)