Clinical Trials Directory

Trials / Completed

CompletedNCT04174417

Effect of Hypotensive Anesthesia on Cerebral Perfusion and Blood Antioxidant Levels and HIF 1a

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The aim of this study to evaluate the patients who underwent controlled hypotensive anesthesia under standardized depth of anesthesia; preoperative and postoperative blood HIF 1a, TAS, TOS measurement and cerebral perfusion evaluation with NIRS and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which blood pressure parameters are related.

Detailed description

Controlled hypotension is the voluntary reversible reduction of arterial blood pressure. Hypotensive anesthesia is a method of anesthesia in which blood pressure is reduced in a controlled manner, especially in certain surgeries. İt reduces intraoperative bleeding and need for blood transfusion and provides a clean surgical vision in narrow-field surgeries or with high bleeding potential. Hypotensive anesthesia can be performed according to mean blood pressure (MBP) or systolic blood pressure (SBP). A non-invasive cerebral oximeter is used to see the changes in the brain due to high oxygen-dependent metabolism during induction and maintenance of anesthesia. Hypoxia inducible factor (HIF) is a transcription factor involved in cell adaptation mechanism activated in response to hypoxia. The biological activity of HIF 1 is determined by the expression and activity of the HIF 1a subunit. Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants. Near Infrared Spectroscopy (NIRS) allows continuous and non-invasive monitoring of cerebral oxygenation. HIF 1a, TAS and TOS are laboratory markers that predict tissue oxygenation and perfusion. Hypotensive anesthesia can be performed according to both MBP and SBP. However, in our study that follow-up MBP is more advantageous/protective, although it is not supported by very strong data. The investigators recommend hypotensive anesthesia compared to MBP; but further studies are needed.

Conditions

Interventions

TypeNameDescription
PROCEDUREsystolic blood pressure (SBP)Systolic blood pressure (SBP) 80-90 mmHg remifentanil infusion was applied to Group 1 patients. In addition to remifentanil infusion, 0.002 μg.kg of glycerol trinitrate (Perlinganit) was administered as an intermittent bolus in patients who needed to achieve target blood pressure. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation. Hemodynamic parameters (HR, SBP, OCD), BIS, SpO2 and NIRS were recorded at 5 minute intervals. At the end of the operation, 3 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory
PROCEDUREmean blood pressure (MBP)For group 2, remifentanil infusion was performed with a mean blood pressure (OCD) of 50-65 mmHg. In addition to remifentanil infusion, 0.002 μg.kg of glycerol trinitrate (Perlinganit) was administered as an intermittent bolus in patients who needed to achieve target blood pressure. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation. Hemodynamic parameters (HR, SBP, OCD), BIS, SpO2 and NIRS were recorded at 5 minute intervals. At the end of the operation, 3 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory.

Timeline

Start date
2018-11-14
Primary completion
2019-05-15
Completion
2019-06-30
First posted
2019-11-22
Last updated
2019-12-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04174417. Inclusion in this directory is not an endorsement.