Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)

Overview

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. MINS is defined as an elevated postoperative troponin level (≥0.03 ng/mL) within 48 hours after surgery. Approximately 400 patients will be enrolled, with 200 patients in each positioning group (supine and prone). The primary outcome is the incidence of MINS, assessed through troponin measurements and electrocardiogram (ECG) findings. Secondary outcomes include intraoperative complications, duration of surgery, and postoperative recovery metrics. The study seeks to determine whether surgical positioning impacts MINS risk, potentially guiding safer surgical practices.

Detailed description

Myocardial Injury after Noncardiac Surgery (MINS) is a significant perioperative complication associated with increased morbidity and mortality. This study investigates whether surgical positioning (supine vs. prone) during percutaneous nephrolithotomy (PNL) influences the incidence of MINS. Patients aged 18 years and older undergoing PNL for kidney stones will be enrolled in a prospective cohort study at \[Institution Name\]. Exclusion criteria include pre-existing cardiovascular disease, elevated baseline troponin levels, or major intraoperative complications. Approximately 400 patients will be divided into two groups based on surgical positioning: 200 in the supine group and 200 in the prone group. Troponin levels will be measured preoperatively and at 24 and 48 hours postoperatively, with MINS defined as a troponin T level ≥0.03 ng/mL. Electrocardiograms (ECGs) will be performed to detect ischemic changes. Secondary outcomes include intraoperative hypotension, surgical duration, and postoperative hospital stay. Data will be analyzed using chi-square tests and logistic regression to adjust for confounders such as age, comorbidities, and surgical duration. The study aims to provide evidence on the impact of positioning on MINS, potentially informing safer surgical protocols for PNL.

Interventions

• Diagnostic test blood sampling
  measuring troponine preoperative and postoperative first and second day

Primary outcome measures

• Incidence of Myocardial Injury after Noncardiac Surgery (MINS) [Time frame: Up to 48 hours post-surgery]

Secondary outcome measures (2)

• Surgical Duration [Time frame: During surgery.]
• Postoperative Hospital Stay [Time frame: From surgery to discharge.]

Eligibility criteria

Inclusion criteria

• Age ≥40 years.
• Patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones.
• Willing and able to provide informed consent.

Exclusion criteria

• Known coronary artery disease, heart failure, or other significant cardiovascular conditions.
• Elevated preoperative troponin levels (≥0.03 ng/mL).
• Major intraoperative complications (e.g., severe bleeding requiring transfusion).
• Inability to comply with study procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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• Li L, Quang TS, Gracely EJ, Kim JH, Emrich JG, Yaeger TE, Jenrette JM, Cohen SC, Black P, Brady LW. A Phase II study of anti-epidermal growth factor receptor radioimmunotherapy in the treatment of glioblastoma multiforme. J Neurosurg. 2010 Aug;113(2):192-8. doi: 10.3171/2010.2.JNS091211. PMID 20345222
• Preston GC, Keene ON, Palmer JL. The effect of ondansetron on the pharmacokinetics and pharmacodynamics of temazepam. Anaesthesia. 1996 Sep;51(9):827-30. doi: 10.1111/j.1365-2044.1996.tb12610.x. PMID 8882243
• Edward GM, Das SF, Elkhuizen SG, Bakker PJ, Hontelez JA, Hollmann MW, Preckel B, Lemaire LC. Simulation to analyse planning difficulties at the preoperative assessment clinic. Br J Anaesth. 2008 Feb;100(2):195-202. doi: 10.1093/bja/aem366. PMID 18211993
• POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S01 PMID 18479744
• Chretien AE, Gagnon-Arsenault I, Dube AK, Barbeau X, Despres PC, Lamothe C, Dion-Cote AM, Lague P, Landry CR. Extended Linkers Improve the Detection of Protein-protein Interactions (PPIs) by Dihydrofolate Reductase Protein-fragment Complementation Assay (DHFR PCA) in Living Cells. Mol Cell Proteomics. 2018 Feb;17(2):373-383. doi: 10.1074/mcp.TIR117.000385. Epub 2017 Dec 4. PMID 29203496
• Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqu PMID 28444280

Identifiers

NCT: NCT06944301 · 3211789

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗