NCT03324477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

6.2 years

First QC Date

October 22, 2017

Last Update Submit

February 11, 2025

Conditions

Transurethral Resection of Prostate Syndrome

Outcome Measures

Primary Outcomes (1)

  • systolic blood pressure

    systolic blood pressure is measured by mmHg

    two hours

Study Arms (2)

preload group

EXPERIMENTAL

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%

coload group

EXPERIMENTAL

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%

Interventions

hypertonic saline 3%DRUG

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

Also known as: hypertonic saline
coload grouppreload group

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I - III.

You may not qualify if:

  • Patient refusal.
  • Patient in whom spinal anesthesia is absolutely contraindicated.
  • Known sensitivity to local anesthetics.
  • Preoperative electrolyte imbalance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Nazmy E Seif, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Manal M Elgohary, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Manar M Elkholy, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 22, 2017

First Posted

October 27, 2017

Study Start

November 1, 2017

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

EG(1)