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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

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

• Patients aged ≥ 19 years

Locations
Other Locations
Republic of Korea
GangnamSeverance Hospital
RECRUITING
Seoul
Contact Information
Primary
sunkyung Park
gsirb@yuhs.ac
82-2-2019-4601
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 40
Treatments
Patients with autonomic dysfunction
Achalasia patients who have autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.
Patients with normal autonomic function
Achalasia patients without autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.
Related Therapeutic Areas
Sponsors
Leads: Gangnam Severance Hospital

This content was sourced from clinicaltrials.gov