An interventional study of NaCl 3% HS and NaCl 3% HS in Transurethral Resection of Prostate Syndrome, sponsored by Ahmed Mohamed ELbadawy. Status unknown at 1 site in Egypt. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by Ahmed Mohamed ELbadawy · Not applicable, Interventional, and Prevention
This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications
The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs [mean BP, HR, CVP \& oxygen saturation (spO2)] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.
164 studies on the registry are indexed under Hyponatremia; 16 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 98 interventional studies indexed under Hyponatremia.
Browse Hyponatremia studies →Ahmed Mohamed ELbadawy is the lead sponsor of 2 studies on the registry; none 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.
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.
patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.
Drug: NaCl 3% HS
patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.
Drug: NaCl 3% HS
patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.
Drug: NaCl 0.9% NS
Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
Also known as: Hypertonic saline
Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
Also known as: Hypertonic saline
Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.
Also known as: Normal saline
Serum sodium level measured in mEq/L
Hyponatremia was defined as a serum sodium \< 130 mEq/L
Time frame: 72 hours
Incidence of TURP syndrome
Occurring TURP syndrome manifestations
Time frame: 72 hours
Need for ICU admission
For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring
Time frame: 72 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Chloride
Ahmed Mohamed ELbadawy