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Completed

NCT Number: NCT03324477

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

hypertonic saline 3%

Drug

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

Other names: hypertonic saline

Primary outcomes

  1. systolic blood pressure

    Time frame: two hours

    systolic blood pressure is measured by mmHg

Sponsors and collaborators

Lead sponsor

Nazmy Edward Seif

Other

Registry information

Official study title

Cardiometrically Evaluated NaCl 3% Coload Versus Preload for TURP. A Randomized Controlled Trial.

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2017
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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