Prophylaxis Versus Treatment for TURP Syndrome.

Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline

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

Study Overview

• Status: Unknown
• Conditions: Transurethral Resection of Prostate Syndrome
• Intervention / Treatment: Drug: NaCl 3% HS; Drug: NaCl 3% HS; Drug: NaCl 0.9% NS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum sodium level measured in mEq/L	Hyponatremia was defined as a serum sodium < 130 mEq/L	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of TURP syndrome	Occurring TURP syndrome manifestations	72 hours
Need for ICU admission	For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring	72 hours

Collaborators and Investigators

• Sponsor: Ahmed Mohamed ELbadawy
• Investigators: Principal Investigator: Ahmed ELbadawy, MD, Faculty of medicine- Cairo University- Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 4, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 23, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: TURP syndrome; hypertonic saline; TURP; hyponatraemia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: N02112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No