A Phase 4 interventional study of hypertonic saline 3% in Transurethral Resection of Prostate Syndrome, sponsored by Nazmy Edward Seif. Completed at 1 site in Egypt. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Nazmy Edward Seif · Phase 4, Interventional, and Prevention
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.
Benign prostatic hyperplasia is common in elderly males, and this group of patients is commonly associated with different comorbidities especially of the cardiovascular system , this make them at risk of many intraoperative complications. The associated adverse effects arising in both the cardiovascular and nervous systems are known as transurethral resection (TUR) syndrome.Therefore TURP patients need meticulous monitoring of hemodynamics and fluid therapy.
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.
100 ASA physical status I-III male patients scheduled to electively undergo transurethral resection of the prostate under spinal subarachnoid block were included in this study
Preload group (Group P):
50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula over 15-20 min before the induction of spinal anaesthesia.
Co-load group (Group C):
50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula at the maximal possible rate at the time of identification of C.S.F .
Nazmy Edward Seif is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 4 ml/kg of hypertonic saline 3% via G14 cannula over 15-20 min before the induction of spinal anaesthesia.
Drug: hypertonic saline 3%
Patients will receive 4 ml/kg of hypertonic saline 3% via G14cannula at the maximal possible rate at the time of identification of C.S.F .
Drug: hypertonic saline 3%
hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma
Also known as: hypertonic saline
systolic blood pressure
systolic blood pressure is measured by mmHg
Time frame: two hours
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Dec 2023, 73 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Nazmy Edward Seif