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

NCT04174417 | Completed

• 1 other identifier: Ayse01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemia During Surgery; Hypoxia, Brain

Keywords

hypotensive anesthesia; HIF 1a; Brain Hypoxia; tissue hypoxia

Outcome Measures

Primary Outcomes (4)

• Evaluation of the relationship between hypotensive anesthesia technique and brain hypoxia by the rate of NIRS

  The investigators used to detect brain hypoxia with Near Infrared Spectroscopy (NIRS) (INVOS 5100 Medtronic). Near Infrared measurement, primary absorbing molecules in tissue are metal complex chromophores such as hemoglobin, bilirubin and cytochrome. The absorption spectra of deoxyhemoglobin (Hb) range between 650-1000 nm, the oxyhemoglobin (Hb02) absorption spectra range between 700-1150 and the cytochrome oxidase aa3 (Caa3) absorption spectra range from 820-840 nm. NIRS measures the ratio of oxyhemoglobin to total hemoglobin at a depth of 2.5-3 cm in the area under the sensor.This ratio represents regional cerebral oxygen (RsO2) saturation. RSO2 below 40% or more than 25% decrease in baseline is associated with neurological dysfunction and side effects. A 15-20% reduction or less than 50% of the baseline is considered a critical threshold and requires action.

  intraoperative 2 hours

• Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by HIF1a

  Under normoxic conditions, HIF 1a protein can hardly be detected, but when hypoxia starts, its expression starts within 2 minutes and peaks at 4-8 hours of hypoxia. 3 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia induction for measure HIF 1a,TAS and TOS. At the end of the operation, 3 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.

  Change from Baseline HIF 1a at 2 hours

• Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TAS

  Plasma TAS and TOS levels are measured with a commercial kit developed by Erel. Values for plasma TAS are expressed in millimeters by the Trolox value per liter. 3 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia induction for measure HIF 1a,TAS and TOS. At the end of the operation, 3 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.

  Change from Baseline TAS levels at 2 hours

• Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TOS

  Measurement for TOS is calibrated with hydrogen peroxide and the results are expressed in micromolar by the hydrogen peroxide value per liter (mmol H2O2 equiv / L). 3 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia induction for measure HIF 1a,TAS and TOS. At the end of the operation, 3 ml of blood was taken again from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory. The collected blood was centrifuged at 2000 x g for 10 minutes and the separated sera were sent to the biochemical laboratory to be stored at -80 ° C until the study was performed.

  Change from Baseline TOS levels at 2 hours

Secondary Outcomes (3)

• surgical satisfaction

  postoperative 1 minute

• bleeding scores

  postoperative 1 minute

• anesthetic consumption

  postoperative 1 minute

Study Arms (2)

systolic blood pressure (SBP)

ACTIVE COMPARATOR

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

Procedure: systolic blood pressure (SBP)

mean blood pressure (MBP)

ACTIVE COMPARATOR

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

Procedure: mean blood pressure (MBP)

Interventions

systolic blood pressure (SBP) 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

systolic blood pressure (SBP)

mean blood pressure (MBP) 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.

mean blood pressure (MBP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia, Brain

Interventions

Blood Pressure; Arterial Pressure

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Hayrettin Daşkaya, MD

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 22, 2019
• Study Start: November 14, 2018
• Primary Completion: May 15, 2019
• Study Completion: June 30, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)