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CompletedNCT03324477Updated Feb 12, 2025

The Hemodynamic Effects of Hypertonic Saline Preload Versus Coload Measured by Non-invasive Cardiometry in Patients Undergoing TURP Surgery

A Phase 4 interventional study of hypertonic saline 3% in Transurethral Resection of Prostate Syndrome, sponsored by Nazmy Edward Seif. Completed at 1 site in Egypt. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Nazmy Edward Seif · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
Male
01

Study summary

This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.

Read the detailed description

Benign prostatic hyperplasia is common in elderly males, and this group of patients is commonly associated with different comorbidities especially of the cardiovascular system , this make them at risk of many intraoperative complications. The associated adverse effects arising in both the cardiovascular and nervous systems are known as transurethral resection (TUR) syndrome.Therefore TURP patients need meticulous monitoring of hemodynamics and fluid therapy.

This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.

100 ASA physical status I-III male patients scheduled to electively undergo transurethral resection of the prostate under spinal subarachnoid block were included in this study

Preload group (Group P):

50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula over 15-20 min before the induction of spinal anaesthesia.

Co-load group (Group C):

50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula at the maximal possible rate at the time of identification of C.S.F .

02

Conditions studied

  • Transurethral Resection of Prostate Syndrome
03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I - III.

Exclusion criteria

Exclusion Criteria:

  • Patient refusal.
  • Patient in whom spinal anesthesia is absolutely contraindicated.
  • Known sensitivity to local anesthetics.
  • Preoperative electrolyte imbalance.
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    preload group

    Patients will receive 4 ml/kg of hypertonic saline 3% via G14 cannula over 15-20 min before the induction of spinal anaesthesia.

    Drug: hypertonic saline 3%

  • Experimental
    coload group

    Patients will receive 4 ml/kg of hypertonic saline 3% via G14cannula at the maximal possible rate at the time of identification of C.S.F .

    Drug: hypertonic saline 3%

Interventions

  • Drughypertonic saline 3%

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

    Also known as: hypertonic saline

05

What researchers measure

Primary outcomes

  1. systolic blood pressure

    systolic blood pressure is measured by mmHg

    Time frame: two hours

06

Study locations

1 site
  • Faculty of Medicine, Cairo University
    Cairo, 11562, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03324477
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
Oct 27, 2017
Start date
Nov 1, 2017
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Last update
Feb 12, 2025

Study contacts

Nazmy E Seif, MD
principal investigator · Cairo University
Manal M Elgohary, MD
principal investigator · Cairo University
Manar M Elkholy, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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