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

Sponsor
Nazmy Edward Seif (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03324477
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
55
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • hypertonic saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. systolic blood pressure [two hours]

      systolic blood pressure is measured by mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nazmy Edward Seif, Clinical Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03324477
    Other Study ID Numbers:
    • 11-2017
    First Posted:
    Oct 27, 2017
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 9, 2022