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Prophylaxis Versus Treatment for TURP Syndrome.

NCT ID: NCT03428451

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-10

Study Completion Date

2018-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Transurethral Resection of Prostate Syndrome

Keywords

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TURP hypertonic saline TURP syndrome hyponatraemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A (Hypertonic saline )

patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.

Group Type ACTIVE_COMPARATOR

NaCl 3% HS

Intervention Type DRUG

Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.

Group B (Hypertonic saline)

patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.

Group Type ACTIVE_COMPARATOR

NaCl 3% HS

Intervention Type DRUG

Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.

Group C (Normal saline)

patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.

Group Type ACTIVE_COMPARATOR

NaCl 0.9% NS

Intervention Type DRUG

Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Interventions

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NaCl 3% HS

Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.

Intervention Type DRUG

NaCl 3% HS

Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.

Intervention Type DRUG

NaCl 0.9% NS

Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Intervention Type DRUG

Other Intervention Names

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Hypertonic saline Hypertonic saline Normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ahmed Mohamed ELbadawy

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed ELbadawy

Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed ELbadawy, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine- Cairo University- Egypt

Locations

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Faculty of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N02112

Identifier Type: -

Identifier Source: org_study_id