Clinical trial NCT04246567: Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
Official title: Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hypoxemia During Surgery
Hypoxia
Keywords: hypotensive anesthesia
HIF 1a
total intravenous anesthesia
inhalation anesthesia
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SCREENING

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.

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

Eligibility criteria: Inclusion Criteria:

* 18-55 years old
* ASA Physical Status Classification System 1
* Undergoing to Elective rhinoplasty

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by HIF1a
timeFrame: Change from Baseline HIF 1a 30th minute (t1), 1st hour (t2) and 2st hour (t3)
measure: Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TAS
timeFrame: Change from Baseline TAS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
measure: Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TOS
timeFrame: Change from Baseline TOS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
Secondary outcomes:
measure: surgical satisfaction
timeFrame: postoperative 1 minute
measure: bleeding scores
timeFrame: postoperative 1 minute
measure: anesthetic consumption for group 1 propofol consumption (mg) and remifentanyl consumption(microgram)
timeFrame: postoperative 1 minute
measure: anesthetic consumption for group 2 N2O2 consumption (ml) and sevoflurane consumption (ml)
timeFrame: postoperative 1 minute
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Hayrettin Daşkaya, MD
role: STUDY_DIRECTOR
References: