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

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ClinicalTrials.gov Identifier: NCT03324477
Recruitment Status : Active, not recruiting
First Posted : October 27, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Nazmy Edward Seif, Cairo University

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.

Condition or disease Intervention/treatment Phase
Transurethral Resection of Prostate Syndrome Drug: hypertonic saline 3% Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Cardiometrically Evaluated NaCl 3% Coload Versus Preload for TURP. A Randomized Controlled Trial.
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
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%
hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma
Other Name: hypertonic saline

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




Primary Outcome Measures :
  1. systolic blood pressure [ Time Frame: two hours ]
    systolic blood pressure is measured by mmHg



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324477


Locations
Egypt
Faculty of Medicine, Cairo University
Cairo, Egypt, 11562
Sponsors and Collaborators
Nazmy Edward Seif
Investigators
Principal Investigator: Nazmy E Seif, MD Cairo University
Principal Investigator: Manal M Elgohary, MD Cairo University
Principal Investigator: Manar M Elkholy, MD Cairo University

Responsible Party: Nazmy Edward Seif, Clinical Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03324477     History of Changes
Other Study ID Numbers: 11-2017
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No