Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827705
• Other study ID #: 2011-KAEK-25 2021/03-14
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2023
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Urolithiasis

Intervention

Other:
• need for Ephedrine hydrochloride
ephedrine dose in hypotension

Locations

Country	Name	City	State
Turkey	Bursa yüksek ihtisas EAH	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Melo PAS, Vicentini FC, Perrella R, Murta CB, Claro JFA. Comparative study of percutaneous nephrolithotomy performed in the traditional prone position and in three different supine positions. Int Braz J Urol. 2019 Jan-Feb;45(1):108-117. doi: 10.1590/S1677-5538.IBJU.2018.0191. — View Citation

Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesi — View Citation

Vernooij LM, van Klei WA, Machina M, Pasma W, Beattie WS, Peelen LM. Different methods of modelling intraoperative hypotension and their association with postoperative complications in patients undergoing non-cardiac surgery. Br J Anaesth. 2018 May;120(5):1080-1089. doi: 10.1016/j.bja.2018.01.033. Epub 2018 Mar 21. — View Citation

Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Perioperatif hypotension and presence of systemic diseases	Systolic blood pressure (SBP) <90 mmHg, mean arterial pressure (MAP) <65 mmHg, or a decrease of more than 20% of baseline	Perioperative period
Primary	Prone position effects on hypotension	Systolic blood pressure (SBP) <90 mmHg, mean arterial pressure (MAP) <65 mmHg, or a decrease of more than 20% of baseline	Perioperative period
Secondary	mortality	death	30 days after the surgery