Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05827705

Collaborator

(none)

153

Enrollment

Location

Actual Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypotension Urolithiasis	Other: need for Ephedrine hydrochloride

Detailed Description

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 patients. 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. We could not find any study comparing systemic disease effects on intraoperative hypotension (hemodynamic parameters) in Prone PCNL surgery.

Study Design

Study Type:

Observational

Actual Enrollment :

153 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Mar 1, 2022

Actual Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group H 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	Other: need for Ephedrine hydrochloride ephedrine dose in hypotension Other Names: Need for ephedrine hidroclorur
Group N 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 Non-Hypotensive patients

Arm

Intervention/Treatment

Group H

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

Other: need for Ephedrine hydrochloride

ephedrine dose in hypotension

Other Names:

Need for ephedrine hidroclorur

Group N

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

mortality [30 days after the surgery]
death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.