Prophylaxis Versus Treatment for TURP Syndrome.

Hanya pengguna terdaftar yang dapat menerjemahkan artikel

Masuk daftar

Tautan disimpan ke clipboard

StatusAktif, tidak merekrut

Sponsor

Ahmed Mohamed ELbadawy

UJI KLINIS: NCT03428451

BioSeek: nct03428451

Kata kunci

Abstrak

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

Deskripsi

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.

tanggal

Terakhir Diverifikasi:	11/30/2018
Pertama Dikirim:	01/25/2018
Perkiraan Pendaftaran Telah Dikirim:	02/03/2018
Pertama Diposting:	02/08/2018
Pembaruan Terakhir Dikirim:	12/22/2018
Pembaruan Terakhir Diposting:	12/25/2018
Tanggal Mulai Studi Sebenarnya:	02/09/2018
Perkiraan Tanggal Penyelesaian Utama:	11/30/2018
Perkiraan Tanggal Penyelesaian Studi:	11/30/2018

Kondisi atau penyakit

Transurethral Resection of Prostate Syndrome

Intervensi / pengobatan

Drug: Group A (Hypertonic saline )

Drug: Group B (Hypertonic saline)

Drug: Group C (Normal saline)

Tahap

Kelompok Lengan

Lengan	Intervensi / pengobatan
Active Comparator: Group A (Hypertonic saline ) patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.	Drug: Group A (Hypertonic saline ) Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
Active Comparator: Group B (Hypertonic saline) patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.	Drug: Group B (Hypertonic saline) Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
Active Comparator: Group C (Normal saline) patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.	Drug: Group C (Normal saline) Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Kriteria kelayakan

Usia yang Layak untuk Belajar	50 Years Untuk 50 Years
Jenis Kelamin yang Layak untuk Belajar	Male
Menerima Relawan Sehat	Iya
Kriteria	Inclusion Criteria: - ASA class I - III BPH patients Exclusion Criteria: - Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation. - Electrolyte imbalance, - Uncontrolled hypertension, - Congestive heart failure or being allergic to local anesthetics.

Hasil

Ukuran Hasil Utama

1. Serum sodium level measured in mEq/L [72 hours]

Hyponatremia was defined as a serum sodium < 130 mEq/L

Ukuran Hasil Sekunder

1. Incidence of TURP syndrome [72 hours]

Occurring TURP syndrome manifestations

2. Need for ICU admission [72 hours]

For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring