- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07669376
Role of Inferior Vena Cava Dispensability Index in Predicting Hypotension of Cement Syndrome in Hip Replacement Surgery Under General Anaesthesia
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Preoperative Settings:
Patients scheduled for elective hip replacement surgeries involving cementation at Ain Shams University Surgery Hospital will be identified and those meeting the inclusion criteria will be approached and enrolled after providing informed consent.
Patients will be confirmed to have fasted for 8 hours before surgery. Medical history will be taken, examinations performed, and laboratory results will be reviewed. A wide bore intravenous line (18-gauge) will be secured, and standard monitoring (ECG, blood pressure measurement, and pulse oximetry) will be applied.
Baseline blood pressure, heart rate, and mean arterial pressure will be recorded.
Intraoperative procedure:
To induce general anaesthesia, we will be using fentanyl (1-2 μg/kg), propofol (1.5-2 mg/kg) and non-depolarizing muscle relaxants (rocuronium or cis-atracurium) according to age, weight, chronic organ function and the needs of the surgery.
All patients are monitored continuously using ECG, pulse oximetry and capnography starting from the beginning of manual ventilation. Ventilatory parameters adjusted to PCO2 <40 mmHg (respiratory rate 12 breaths per minute,), with a tidal volume of 6 to 8 ml/kg, positive end-expiratory pressure (PEEP) of 6 cmH2O and inspired oxygen fraction (FiO2) of 50.
Noninvasive blood pressure measurements (mean arterial pressure (MAP) are obtained at 10 min intervals although the operation, an additional measurement is obligatory 2 min after induction, drug administration and during measurement of IVC-DI and 5 min pre- and post-cementing for 15 min, all measurements will be performed in the semi-recumbent position (head elevated 30°).
The inferior vena cava will be visualized in B-mode using ultrasound machine with Low-frequency curvilinear probe (2-5 MHz) or phased-array probe while patient in supine position the probe will be placed in subxiphoid (subcoastal) area, just below the sternum (from a longitudinal paramedian subxiphoid view). IVC can be differentiated from the aorta utilizing pulse wave Doppler. With M-mode imaging, done 2 to 3 cm distant to the right atrium, The last section of the vein, which is proximal to the hepatic vein inflow and 0.5-3 cm from the right atrium, will be selected, with Use of the callipers to measure the maximum IVC diameter (Dmax) during inspiration and the minimum IVC diameter (Dmin) during expiration. Then the IVC distensibility index is calculated and recorded using the formula: IVC distensibility index = [(maximum diameter on inspiration-minimum
diameter on expiration)/minimum diameter on expiration (Lujan Varas et al, 2015). All IVC measurements are taken post intubation 3 times and the mean value recorded. Patients will be divided into two groups.
Group A: those who develop hypotension post cementation. Group B: those who do not develop hypotension post cementation. In the study Hypotension will be defined as MAP < 60 mmHg or a decrease in SBP by > 20% from baseline. In case of persistent mean arterial pressure less than 55 mmHg, a 6 mg dose of ephedrine will be titrated. After two doses of ephedrine, another fluid bolus of 5 ml/kg will be given, followed by another dose of ephedrine until hypotension is corrected.
The primary outcome:
Cut off value of IVC-DI at which we can predict the incidence of hypotension following cementing in orthopedic surgery.
Secondary outcomes Intra-operative hemodynamic, the need of vasoactive drug administration, and the amount of fluid administered.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
-
-
Abbassia
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Cairo, Abbassia, Egypt, 00202
- Ain Shams University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- participants must be 18 years of age or older and provide written consent. Patients scheduled for elective hip replacement surgery under general anaesthesia with an American Society of Anesthesiologists (ASA) physical status of I or III based on preoperative assessment.
Exclusion Criteria:
▪ Patient refusal to participate.
- ASA status IV or above.
- Patients with BMI more than 30 kg/m².
- Pre-existing hypotension, cardiac disease (such as heart failure or coronary artery disease), pulmonary disease (such as chronic obstructive pulmonary disease), renal disease (such as chronic kidney disease), hepatic disease (such as cirrhosis), coagulopathy or bleeding disorders, pregnancy or lactation, severe intra-operative blood loss requiring blood transfusion.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cut off value of IVC-DI at which we can predict the incidence of hypotension following cementing in orthopedic surgery.
Časové okno: All IVC measurements are taken 10 minutes post intubation
|
Cut off value of IVC-DI at which we can predict the incidence of hypotension following cementing in orthopedic surgery.
|
All IVC measurements are taken 10 minutes post intubation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Intra-operative hemodynamic(blood pressure)
Časové okno: At 10 minutes intervals all through the operation, an additional measurement is obligatory 2 minutes after induction, drug administration and during measurement of IVC-DI and 5 minutes pre- and post-cementing for 15 minutes
|
In the study Hypotension will be defined as MAP < 60 mmHg or a decrease in SBP by > 20% from baseline.
|
At 10 minutes intervals all through the operation, an additional measurement is obligatory 2 minutes after induction, drug administration and during measurement of IVC-DI and 5 minutes pre- and post-cementing for 15 minutes
|
|
The need of vasoactive drug administration
Časové okno: Post cement insertion for 30 minutes
|
In case of persistent(>5minutes) mean arterial pressure less than 55 mmHg, a 6 mg dose of ephedrine will be titrated.
|
Post cement insertion for 30 minutes
|
|
The Amount of Fluid administered.
Časové okno: Post cement insertion for 30 minutes
|
After two doses of ephedrine, another fluid bolus of 5 ml/kg will be given, followed by another dose of ephedrine until hypotension is corrected.
|
Post cement insertion for 30 minutes
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Azza Mohamed Lotfy Youssef Nasr, Assistant Professor Phd, Ain Shams University
- Ředitel studie: Aya Ali Mahmoud Bayoumy, Lecturer Phd, Ain Shams University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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