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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital will be eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sunkyung Park | Contact | 82-2-2019-4601 | gsirb@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangnamSeverance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32504156 | Background | 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. |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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|
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| D004066 | Digestive System Diseases |