search
Back to results

Prophylaxis Versus Treatment for TURP Syndrome.

Primary Purpose

Transurethral Resection of Prostate Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NaCl 3% HS
NaCl 3% HS
NaCl 0.9% NS
Sponsored by
Ahmed Mohamed ELbadawy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transurethral Resection of Prostate Syndrome focused on measuring TURP, hypertonic saline, TURP syndrome, hyponatraemia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A (Hypertonic saline )

Group B (Hypertonic saline)

Group C (Normal saline)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum sodium level measured in mEq/L
Hyponatremia was defined as a serum sodium < 130 mEq/L

Secondary Outcome Measures

Incidence of TURP syndrome
Occurring TURP syndrome manifestations
Need for ICU admission
For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring

Full Information

First Posted
January 26, 2018
Last Updated
December 23, 2018
Sponsor
Ahmed Mohamed ELbadawy
search

1. Study Identification

Unique Protocol Identification Number
NCT03428451
Brief Title
Prophylaxis Versus Treatment for TURP Syndrome.
Official Title
Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed ELbadawy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transurethral Resection of Prostate Syndrome
Keywords
TURP, hypertonic saline, TURP syndrome, hyponatraemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Hypertonic saline )
Arm Type
Active Comparator
Arm Description
patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.
Arm Title
Group B (Hypertonic saline)
Arm Type
Active Comparator
Arm Description
patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.
Arm Title
Group C (Normal saline)
Arm Type
Active Comparator
Arm Description
patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.
Intervention Type
Drug
Intervention Name(s)
NaCl 3% HS
Other Intervention Name(s)
Hypertonic saline
Intervention Description
Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
Intervention Type
Drug
Intervention Name(s)
NaCl 3% HS
Other Intervention Name(s)
Hypertonic saline
Intervention Description
Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9% NS
Other Intervention Name(s)
Normal saline
Intervention Description
Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.
Primary Outcome Measure Information:
Title
Serum sodium level measured in mEq/L
Description
Hyponatremia was defined as a serum sodium < 130 mEq/L
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Incidence of TURP syndrome
Description
Occurring TURP syndrome manifestations
Time Frame
72 hours
Title
Need for ICU admission
Description
For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring
Time Frame
72 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Adult male BPH patients
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed ELbadawy, MD
Organizational Affiliation
Faculty of medicine- Cairo University- Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Prophylaxis Versus Treatment for TURP Syndrome.

We'll reach out to this number within 24 hrs