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

Phase 4

Completed

• Conditions: Transurethral Resection of Prostate Syndrome
• Interventions: Drug: hypertonic saline 3%

• Registration Number: NCT03324477
• Lead Sponsor: Nazmy Edward Seif

Brief 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.

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 .

Study Timeline

• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-27
• Study Start: 2017-11-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
systolic blood pressure	two hours	systolic blood pressure is measured by mmHg

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt