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

Not Applicable

Completed

• Conditions: Perfusion
• Interventions: Drug: Ringer-Lactate Infusion Solution Bag; Drug: sodium chloride; Drug: Hydroxyethylstarch

• Registration Number: NCT03048162
• Lead Sponsor: Tokat Gaziosmanpasa University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-02-13
• Status Verified: 2017-05
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer-Lactate Infusion Solution Bag	Ringer-Lactate Infusion Solution Bag	Ringer's lactate, 500 ml, one package in 30 minutes
sodium chloride	sodium chloride	0.9% isotonic sodium chloride, 500 ml, one package in 30 minutes
Hydroxyethylstarch	Hydroxyethylstarch	6% hydroxyethylstarch, 500 ml, one package in 30 minutes

Primary Outcome Measures

Name	Time	Method
Perfusion index	six months	The perfusion of the tissues

Secondary Outcome Measures

Name	Time	Method
Pulse variability index	six months	The intravenous fluid requirement of the tissues
Blood pressure	six months	Non-invasive lood pressure
Heart rate	six months	Heart rate
Oxygen saturation	six months	Blood oxygen saturation using pulse oximeter

Trial Locations

Locations (1)

Gaziosmanpasa University; 🇹🇷 Tokat, Turkey