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

Transurethral Resection of Prostate Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03324477
• Other study ID #: 11-2017
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: August 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transurethral Resection of Prostate Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure	systolic blood pressure is measured by mmHg	two hours