Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels

NCT04246567 | Suspended

• 1 other identifier: Ayse02
• 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 with total intravenous anesthesia or inhalation anesthesia; preoperative and 30. ,60. ,120. second of intraoperative period blood HIF 1a, TAS, TOS measurement and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which hypotensive anesthesia technique is related.

Conditions

Hypoxemia During Surgery; Hypoxia

Keywords

hypotensive anesthesia; HIF 1a; total intravenous anesthesia; inhalation anesthesia

Outcome Measures

Primary Outcomes (3)

• 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. 5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 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 30th minute (t1), 1st hour (t2) and 2st hour (t3)

• 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. 5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 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 30th minute (t1), 1st hour (t2) and 2st hour (t3)

• 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).5 ml blood was taken into MiniCollect® tubes from the venous cannula placed before anesthesia (t0) induction for measure HIF 1a,TAS and TOS. 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation 5 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 30th minute (t1), 1st hour (t2) and 2st hour (t3)

Secondary Outcomes (4)

• surgical satisfaction

  postoperative 1 minute

• bleeding scores

  postoperative 1 minute

• anesthetic consumption for group 1 propofol consumption (mg) and remifentanyl consumption(microgram)

  postoperative 1 minute

• anesthetic consumption for group 2 N2O2 consumption (ml) and sevoflurane consumption (ml)

  postoperative 1 minute

Study Arms (2)

Total intravenous anesthesia technique for group 1 patients

ACTIVE COMPARATOR

Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 6-10 mg / kg / h propofol and 0.0,4mcg / kg remifentanyl infusion / min. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. 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,TOF and SpO2 were recorded at 5 minute intervals. Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 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

Procedure: Mean Blood Pressure (MBP); Drug: Add to 0.5 mcg / kg fentanyl.

Inhalation anesthesia technique for group 2 patients

ACTIVE COMPARATOR

Procedure/Surgery:Mean Blood Pressure (MBP) Mean blood pressure (MBP) 50-65 mmHg was applied with 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA to provide a value of BIS between 40-60. When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl. 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,TOF and SpO2 were recorded at 5 minute intervals. Blood samples were taken from patients during preop preparation (t0), 30th minute (t1), 1st hour (t2) and 2nd hour (t3) of the operation. 5 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

Procedure: Mean Blood Pressure (MBP); Drug: Add to 0.5 mcg / kg fentanyl.

Interventions

Mean Blood Pressure (MBP) PROCEDURE

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

Inhalation anesthesia technique for group 2 patients; Total intravenous anesthesia technique for group 1 patients

Add to 0.5 mcg / kg fentanyl. DRUG

When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl.

Inhalation anesthesia technique for group 2 patients; Total intravenous anesthesia technique for group 1 patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• ASA Physical Status Classification System 1
• Undergoing to Elective rhinoplasty

You may not qualify if:

• Patients have any autoimmune disease
• Smoking of patients
• Development of any allergic reaction during the procedure
• Failure to collect blood to be examined at the appropriate time
• Body mass index is less than 19 or greater than 30
• 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

Interventions

Arterial Pressure; Fentanyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 divided 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: SPONSOR

Model Details: A total of 60 ASA 1 patients aged between 18-55 who underwent elective rhinoplasty surgery were included the study.The patients were divided into two groups. One group received hypotensive anesthesia with total intravenous anesthesia technique according to MBP and the other group received hypotensive anesthesia with inhalation anesthesia technique. Blood samples were taken from all patients before anesthesia induction and 30. ,60. ,120. second of intraoperative period 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: January 22, 2020
• First Posted: January 29, 2020
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2021
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

TU (1)