Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

May 7, 2023 updated by: Seyda Efsun Ozgunay, Bursa Yüksek İhtisas Education and Research Hospital

The Effects of Position and Predictive Factors on Hypotension in Patients Undergoing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16290
        • Bursa yüksek ihtisas EAH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Percutaneous access was performed in all patients with fluoroscopy in the prone position after the ureteral catheter placement in the lithotomy position as standard.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Perioperative period
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
Perioperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days after the surgery
death
30 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Seyda E Ozgunay, 1, Bursa yüksek ihtisas EAH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 7, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2021/03-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocal can be shared.

IPD Sharing Time Frame

One year

IPD Sharing Access Criteria

Study Protocol

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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