Clinical trial NCT03048162: The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
Official title: The Evaluation of the Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perfusion
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perfusion index
timeFrame: six months
Secondary outcomes:
measure: Heart rate
timeFrame: six months
measure: Blood pressure
timeFrame: six months
measure: Oxygen saturation
timeFrame: six months
measure: Pulse variability index
timeFrame: six months
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Seval Ekerer, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa University
name: Mustafa Suren, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa University
name: Serkan Karaman, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa University
name: Tugba Karaman, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa University
name: Hakan Tapar, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa University
name: Aynur Sahin, Dr
role: PRINCIPAL_INVESTIGATOR
References: