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Completed

NCT Number: NCT05827705

Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa yüksek ihtisas EAH

Bursa, 16290, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

need for Ephedrine hydrochloride

Other

ephedrine dose in hypotension

Other names: Need for ephedrine hidroclorur

Primary outcomes

  1. 1.Perioperatif hypotension and presence of systemic diseases

    Time frame: Perioperative period

    Systolic blood pressure (SBP) <90 mmHg, mean arterial pressure (MAP) <65 mmHg, or a decrease of more than 20% of baseline

  2. Prone position effects on hypotension

    Time frame: Perioperative period

    Systolic blood pressure (SBP) <90 mmHg, mean arterial pressure (MAP) <65 mmHg, or a decrease of more than 20% of baseline

Secondary outcomes

  1. mortality

    Time frame: 30 days after the surgery

    death

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

The Effects of Position and Predictive Factors on Hypotension in Patients Undergoing Prone Percutaneous Nephrolithotomy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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