The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index

NCT ID: NCT03048162

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2017-05-15

Brief Summary

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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.

Detailed Description

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Intravenous volume replacement alter the dynamics of microcirculation. Perfusion index and pulse variability index are the recent parameters to evaluate the tissue microcirculatory condition. 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 taken to recovery room in the operating theatre and wait for 15 minutes to balance the skin temperature of the patients to the environment. Patients will be randomly divided into three groups using closed envelope technique as Group L (received 500 ml of Ringer's lactate), Group S (500 ml of saline) and Group H (received 500 ml of 6% hydroxyethylstarch). 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.

Conditions

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Perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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sodium chloride

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

Group Type ACTIVE_COMPARATOR

sodium chloride

Intervention Type DRUG

500 ml of 0.9% isotonic sodium chloride

Hydroxyethylstarch

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

Group Type ACTIVE_COMPARATOR

Hydroxyethylstarch

Intervention Type DRUG

500 ml of 6% Hydroxyethylstarch

Ringer-Lactate Infusion Solution Bag

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

Group Type ACTIVE_COMPARATOR

Ringer-Lactate Infusion Solution Bag

Intervention Type DRUG

500 ml of Ringer-Lactate Infusion Solution Bag

Interventions

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sodium chloride

500 ml of 0.9% isotonic sodium chloride

Intervention Type DRUG

Hydroxyethylstarch

500 ml of 6% Hydroxyethylstarch

Intervention Type DRUG

Ringer-Lactate Infusion Solution Bag

500 ml of Ringer-Lactate Infusion Solution Bag

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not to participate in the study
* presence of peripheral vascular disease
* a history of upper extremity surgery
* presence of any kind of psychiatric disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Serkan Dogru

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seval Ekerer, Dr

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Mustafa Suren, Dr

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Serkan Karaman, Dr

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Tugba Karaman, Dr

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Hakan Tapar, Dr

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Aynur Sahin, Dr

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa University

Locations

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Gaziosmanpasa University

Tokat Province, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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OMU KAEK 2016/390

Identifier Type: -

Identifier Source: org_study_id

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