Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

NCT ID: NCT05827705

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Hypotension Urolithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

need for Ephedrine hydrochloride

Intervention Type OTHER

ephedrine dose in hypotension

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

No interventions assigned to this group

Interventions

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need for Ephedrine hydrochloride

ephedrine dose in hypotension

Intervention Type OTHER

Other Intervention Names

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Need for ephedrine hidroclorur

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Seyda Efsun Ozgunay

Asocc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyda E Ozgunay, 1

Role: PRINCIPAL_INVESTIGATOR

Bursa Yüksek İhtisas EAH

Locations

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Bursa yüksek ihtisas EAH

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23835589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29661385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30521168 (View on PubMed)

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. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.

Reference Type RESULT
PMID: 26083768 (View on PubMed)

Other Identifiers

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2011-KAEK-25 2021/03-14

Identifier Type: -

Identifier Source: org_study_id

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