Cement SyndromeNCT07669376
Role of Inferior Vena Cava Dispensability Index in Predicting Hypotension of Cement Syndrome in Hip Replacement Surgery Under General Anaesthesia
An observational study of Cement Syndrome and Hypotension and Shock, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate ICV distensibility index for predicting the incidence of hypotension following cementation in orthopedic hip replacement surgery in patient undergoing general anaesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cement Syndrome, Hypotension and Shock
- What is being tested?
- Ultrasound measurement of IVC
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2025to 20 Jun 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from primary care clinic who are scheduled for Hip Replacement Surgery
Who may be able to join
- 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.
Who cannot join
- ▪ 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate ICV distensibility index for predicting the incidence of hypotension following cementation in orthopedic hip replacement surgery in patient undergoing general anaesthesia
Read the detailed description
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.
- Conditions
- Cement Syndrome, Hypotension and Shock
- Being tested
- Ultrasound measurement of IVC
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurement of IVCDevice
Ultrasound measurement of IVC to calculate IVC Dispensability index.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut off value of IVC-DI at which we can predict the incidence of hypotension following cementing in orthopedic surgery.
Cut off value of IVC-DI at which we can predict the incidence of hypotension following cementing in orthopedic surgery.
Measured: All IVC measurements are taken 10 minutes post intubation
Secondary outcomes (3)
Intra-operative hemodynamic(blood pressure)
In the study Hypotension will be defined as MAP < 60 mmHg or a decrease in SBP by > 20% from baseline.
Measured: 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
In case of persistent(>5minutes) mean arterial pressure less than 55 mmHg, a 6 mg dose of ephedrine will be titrated.
Measured: Post cement insertion for 30 minutes
The Amount of Fluid administered.
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.
Measured: Post cement insertion for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start20 Dec 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azza Mohamed Lotfy Youssef Nasr, Assistant Professor Phd, Study director, Ain Shams UniversityAya Ali Mahmoud Bayoumy, Lecturer Phd, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669376
- Sponsor's protocol ID
- MS 724/2025
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided