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NCT Number: NCT03048162

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

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.

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Key information

Conditions

Perfusion

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Chloride

Drug

500 ml of 0.9% isotonic sodium chloride

Hydroxyethylstarch

Drug

500 ml of 6% Hydroxyethylstarch

Ringer-Lactate Infusion Solution Bag

Drug

500 ml of Ringer-Lactate Infusion Solution Bag

Primary outcomes

  1. Perfusion index

    Time frame: six months

    The perfusion of the tissues

Secondary outcomes

  1. Heart rate

    Time frame: six months

    Heart rate

  2. Blood pressure

    Time frame: six months

    Non-invasive lood pressure

  3. Oxygen saturation

    Time frame: six months

    Blood oxygen saturation using pulse oximeter

  4. Pulse variability index

    Time frame: six months

    The intravenous fluid requirement of the tissues

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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