Clinical Trials Logo

Clinical Trial Summary

Early detection of fluid accumulation in alveolar, interstitial and intracellular compartments of the lung due to intravascular absorption of irrigation fluid of PNL guided by lung ultrasound by detection of sonographic B lines.


Clinical Trial Description

Study protocol: Anesthetic technique:- After adequate pre-oxygenation for 3-5 min, General anesthesia will be induced by intravenous lidocaine 60 mg, propofol (2mg/kg) and cis-atracurium (0.15 mg/ kg) to facilitate endotracheal intubation by a cuffed endotracheal tube (size 6.5-7.5-mm), then the patient will be connected to mechanical ventilation which will be maintained with an 8 ml/ kg tidal volume, and ventilation frequency well be adjusted to maintain end-tidal CO2 between 30-35 mmHg. Anesthesia will be maintained with isoflurane (0.8-1.0%) in a mixture of oxygen and air (50:50%) and cis-atracurium (0.03 mg/ kg) and maintained every 20 min. Standard monitoring will be used intraoperatively including non-invasive arterial blood pressure, electrocardiography, end-tidal CO2, peripheral oxygen saturation and esophageal core temperature. Patients will receive one liter of normal saline infused over the first 2 hours intraoperatively as their fasting requirements and will be infused with 3 ml/kg/hour of Ringer's acetate as a maintenance fluid. Intraoperative hypotension (more than 20% decrease of the baseline of the patient ) will be treated by a bolus dose of crystalloid (4 ml/kg) as well as a bolus dose of ephedrine (3 mg). Atropine (0.5 mg) will be used to treat bradycardia if the heart rate is <60 beat/min. At end of surgery, isoflurane will be discontinued, and neuromuscular block will be antagonized using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), intravenous paracetamol will be given as analgesia and boluses of fentanil Intraoperative as needed . Extubation will performed when patients began breathing spontaneously and were able to respond to verbal requests and discharge to post-Anesthesia Care Unit (PACU) but if the patient is not fulfilling criteria of extubation so discharge will be to Intensive care unit (ICU). If acute Postoperative lung congestion occurs with postoperative hypoxemia and desaturation, it will be treated with furosemide. Blood samples will be collected for CBC, ABG and electrolytes as sodium and potassium Pre-operative, intraoperative and Immediately Post-operative. Lung ultrasound scan technique: - Each patient will be assessed for the presence of B-lines before induction of anesthesia and after end of anesthesia. A curved 2-6-MHz probe of Mindray machine will be used to do a series of scans with the patient in the supine position by applying the probe perpendicular to the skin over intercostal spaces along anatomical reference lines. More precisely, we will scan the anterolateral hemithoraxes along the parasternal, midclavicular, anterior axillary and mid-axillary lines. The left hemithorax will be scanned from the second to the fourth intercostal space, whereas the right lung will be scanned from the second to the fifth intercostal space, giving a total of 28 scanning sites. The edematous lung shows B-lines as vertical narrow bands originating from the pleural line and extending to the bottom of the image. A B-line score of ≤5 will be considered a normal sonographic pattern, since a few B-lines can be present in healthy subjects, especially above the diaphragm. Data collection:- Patient characteristics - Age - Sex - Medical disease - Drug intake Operative data - Mean arterial blood pressure (MAP), heart rate and peripheral oxygen saturation during the following times (before induction of anesthesia, every 15 minutes after intubation, and at the end of surgery) - Intraoperative complication and interventions. - Duration of surgery - Duration of anesthesia - Type, volume and height of irrigation fluid. - Ultrasound guided extravascular lung water. Postoperative data - Hemoglobin assessment. - Serum sodium level. - Serum potassium level. - Arterial blood gases (ABG). - Ultrasound guided extravascular lung water. Statistical analysis:- ●Descriptive analysis Statistical analysis will be carried out by the SPSS statistical software package version 26.0 (IBM/SPSS, Inc., Chicago, IL). Baseline characteristics will be defined using descriptive statistics. Categorical variables were stated as an absolute number (n) and a relative frequency (%), and continuous variables will be represented as a median (interquartile range) or as a mean (± SD), depending on the normality of the distribution. The normality of distribution will be tested by the one-sample Kolmogorov-Smirnov test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06141746
Study type Observational
Source Assiut University
Contact Hala A Hashem
Phone 01145502643
Email Halahashem797@gmail.com
Status Not yet recruiting
Phase
Start date April 2024
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05574517 - Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter N/A
Completed NCT02764008 - The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration Phase 4
Recruiting NCT03907930 - Conventional PCNL Versus Tubeless PCNL N/A
Not yet recruiting NCT06266793 - Comparison of Holmium Laser and Thulium Laser for Mini PCNL N/A
Completed NCT05467878 - The Effect of Anesthesia on Pain in Percutaneous Nephrolithotomy
Completed NCT04340037 - Prediction of Sepsis After Percutaneous Nephrolithotomy
Not yet recruiting NCT03178292 - Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy N/A
Completed NCT04346134 - Mini- Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy for High Density Renal Stones N/A
Not yet recruiting NCT04943081 - Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease N/A
Not yet recruiting NCT04196270 - The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block Phase 4
Not yet recruiting NCT03016650 - Opioid-sparing Effect of Intravenous Ibuprofen Phase 4
Completed NCT05855057 - Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment
Not yet recruiting NCT05725083 - Lower Thoracic Epidural vs Erector Spinae Block for PNL N/A
Completed NCT05947435 - Tranexamic Acid in Percutaneous Nephrolithotomy N/A
Recruiting NCT05077007 - Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers N/A
Completed NCT03897933 - Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study
Recruiting NCT05661175 - Application of One-handed Lithotripsy in Percutaneous Nephrolithotomy N/A
Recruiting NCT06393062 - Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy N/A
Recruiting NCT05012215 - Paravertebral Versus Caudal Block in Pediatric PCNL N/A
Recruiting NCT04856722 - Mini-PNL, RIRS, and ESWL for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones N/A