NCT03048162

Brief Summary

This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

February 4, 2017

Last Update Submit

May 15, 2017

Conditions

Perfusion

Outcome Measures

Primary Outcomes (1)

  • Perfusion index

    The perfusion of the tissues

    six months

Secondary Outcomes (4)

  • Heart rate

    six months

  • Blood pressure

    six months

  • Oxygen saturation

    six months

  • Pulse variability index

    six months

Study Arms (3)

sodium chloride

ACTIVE COMPARATOR

0.9% isotonic sodium chloride, 500 ml, one package in 30 minutes

Drug: sodium chloride

Hydroxyethylstarch

ACTIVE COMPARATOR

6% hydroxyethylstarch, 500 ml, one package in 30 minutes

Drug: Hydroxyethylstarch

Ringer-Lactate Infusion Solution Bag

ACTIVE COMPARATOR

Ringer's lactate, 500 ml, one package in 30 minutes

Drug: Ringer-Lactate Infusion Solution Bag

Interventions

sodium chlorideDRUG

500 ml of 0.9% isotonic sodium chloride

sodium chloride
HydroxyethylstarchDRUG

500 ml of 6% Hydroxyethylstarch

Hydroxyethylstarch
Ringer-Lactate Infusion Solution BagDRUG

500 ml of Ringer-Lactate Infusion Solution Bag

Ringer-Lactate Infusion Solution Bag

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having a fasting period of 8 hours
  • quit smoking for 8 hours before the procedure

You may not qualify if:

  • not to participate in the study
  • presence of peripheral vascular disease
  • a history of upper extremity surgery
  • presence of any kind of psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sodium ChlorideHydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsStarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Seval Ekerer, Dr

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

  • Mustafa Suren, Dr

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

  • Serkan Karaman, Dr

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

  • Tugba Karaman, Dr

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

  • Hakan Tapar, Dr

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

  • Aynur Sahin, Dr

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2017

First Posted

February 9, 2017

Study Start

February 13, 2017

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

TU(1)