Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

Completed

• Conditions: Hypotension; Urolithiasis
• Interventions: Other: need for Ephedrine hydrochloride

• Registration Number: NCT05827705
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary

This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged \>18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position.

Detailed Description

This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged \>18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position. Age, gender, body mass index(BMI), smoking, type of anaesthesia, duration of anaesthesia and surgery were recorded.

The ECG, SpO2, and non-invasive blood pressure values were recorded intraoperatively. Preoperative and postoperative 12th hour Hb,BUN, Cr,Na,K and Cl were measured in a blood sample. Isotonic was used as an intravenous fluid in all participants. In treatment of hypotension routine ephedrine treatments were recorded.

In the literature, studies in PCNL surgery have focused on data such as method, duration of bleeding and fluoroscopy, electrolyte-metabolic changes, and complications such as fever, hypothermia, pleural damage, and hospital stay. A limited number of studies have focused on bleeding and hemodynamics in comparing surgical methods in the prone and supine positions. the investigators could not find any study comparing systemic disease effects on intraoperative hypotension (hemodynamic parameters) in Prone PCNL surgery.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Patients aged >18 years and ASA I -III who underwent general or regional anaesthesia were included in the study.

Exclusion Criteria

• Patients who received preoperative vasopressor, inotropic infusion, erythrocyte and fresh frozen plasma (FFP), anaemia, uncontrolled coagulopathies, pregnancy, immunodeficiency, ASA class IV and emergency surgeries.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group H	need for Ephedrine hydrochloride	General anaesthesia was induced by Propofol (2 mg/kg) IV, Rocuronium (0.6 mg/kg) and Fentanyl (2 μg/kg) IV, and maintained with sevoflurane and Epidural anesthesia, intraoperative Hypotensive patients

Primary Outcome Measures

Name	Time	Method
Prone position effects on hypotension	Perioperative period	Systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<65 mmHg, or a decrease of more than 20% of baseline
1.Perioperatif hypotension and presence of systemic diseases	Perioperative period	Systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<65 mmHg, or a decrease of more than 20% of baseline

Secondary Outcome Measures

Name	Time	Method
mortality	30 days after the surgery	death

Trial Locations

Locations (1)

Bursa yüksek ihtisas EAH; 🇹🇷 Bursa, Turkey