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

NCT ID: NCT03324477

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2023-12-30

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 .

Conditions

Transurethral Resection of Prostate Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

hypertonic saline 3%

Intervention Type: DRUG

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

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 .

Group Type: EXPERIMENTAL

hypertonic saline 3%

Intervention Type: DRUG

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

Interventions

hypertonic saline 3%

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

Intervention Type: DRUG

Other Intervention Names

hypertonic saline

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Nazmy Edward Seif

OTHER

Sponsor Role: lead

Responsible Party

Nazmy Edward Seif

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nazmy E Seif, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Manal M Elgohary, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Manar M Elkholy, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

11-2017

Identifier Type: -

Identifier Source: org_study_id