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

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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

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Hypoxemia During Surgery Hypoxia, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 60 ASA 1-2 patients aged between 18-75 who underwent elective rhinoplasty and orthognathic surgery were included the study.The patients were divided into two groups. One group received hypotensive anesthesia according to MBP an done group received SBP. Continuous regional cerebral oxygen saturation was monitored by NIRS in both groups. Blood samples were taken from all patients before anesthesia induction and at the and of the operation and stored for TAS, TOS, HIF 1a. At the and of the operation patients were fallowed in the post anesthesia care unit for 30 minutes and pain and nause vomiting scores were evaluated. İn addition, surgical satisfaction and bleeding scores and anesthetic consumption of both groups were recorded

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

The investigators diveded the patients to two groups. Patients were divided into two groups with a lottery. Surgeons did not know which hypotensive anesthesia technique were used. And surgeons evaluated surgical satisfaction and bleeding scores

Study Groups

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systolic blood pressure (SBP)

Systolic blood pressure (SBP) for group 1 patients 80-90 mmHg

Group Type ACTIVE_COMPARATOR

systolic blood pressure (SBP)

Intervention Type PROCEDURE

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

mean blood pressure (MBP)

Mean blood pressure (MBP) for group 2 patients 50-65 mmHg

Group Type ACTIVE_COMPARATOR

mean blood pressure (MBP)

Intervention Type PROCEDURE

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.

Interventions

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systolic 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

Intervention Type PROCEDURE

mean 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old
* ASA Physical Status Classification System 1-2
* Undergoing to Elective rhinoplasty or maxillofacial surgery

Exclusion Criteria

* 1\. Those with SVO history 2. Patients with carotid stenosis and cardiac failure 3. Chronic smoking 4. Patients with allergies to drugs to be used 5. Patients without intraoperative hypotension 6. Presence of morbid obesity (BMI\> 40 kg / m2) 7. Patients who refused to participate in the study

Termination criteria

1. Development of severe hypotension and bradycardia during measurements
2. Development of severe drug allergy during follow-up
3. In the event of any complications related to the surgical procedure

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No