Position and Predictive Factors of Hypotension in Prone Percutaneous Nephrolithotomy

NCT05827705 | Completed DMC

• 1 other identifier: 2011-KAEK-25 2021/03-14
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Urolithiasis

Keywords

Hypotension; prone position; nephrolithotomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• mortality

  30 days after the surgery

Study Arms (2)

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

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

Interventions

need for Ephedrine hydrochloride OTHER

ephedrine dose in hypotension

Also known as: Need for ephedrine hidroclorur

Group H

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients aged \>18 years
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients aged \>18 years and ASA I -III who underwent general or regional anaesthesia were included in the study.

You may not qualify if:

• Patients who received preoperative vasopressor, inotropic infusion, erythrocyte and fresh frozen plasma (FFP), anaemia, uncontrolled coagulopathies, pregnancy, immunodeficiency, ASA class IV and emergency surgeries.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa yüksek ihtisas EAH

Bursa, 16290, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23835589 BACKGROUND

• 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.

  PMID: 29661385 BACKGROUND

• 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.

  PMID: 30521168 BACKGROUND

• 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.

  PMID: 26083768 RESULT

MeSH Terms

Conditions

Hypotension; Urolithiasis

Interventions

Health Services Needs and Demand; Ephedrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Seyda E Ozgunay, 1

  Bursa Yüksek İhtisas EAH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asocc Prof

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 25, 2023
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year
• Access Criteria: Study Protocol

Locations

TU (1)