Hypoxia Clinical Trial
Official title:
Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
NCT number | NCT04246567 |
Other study ID # | Ayse02 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | January 2021 |
Verified date | May 2020 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 60 |
Est. completion date | January 2021 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | surgical satisfaction | At the end of the surgery surgeons evaluated surgical satisfaction. the investigators used surgeon satisfaction score which one is performing like that 1- bad 2-moderate 3-good 4-excellent | postoperative 1 minute | |
Secondary | bleeding scores | At the end of the surgery surgeons evaluated bleeding scores. the investigators used bleeding score which one is performing like that 0-No bleeding 1-minor bleeding no aspiration required 2- Minor bleeding, aspiration required 3-minor bleeding, frequent aspiration required, 4-Moderate bleeding, visible only with aspiration 5- Severe bleeding, frequent aspiration required and very hard to perform surgery | postoperative 1 minute | |
Secondary | anesthetic consumption for group 1 propofol consumption (mg) and remifentanyl consumption(microgram) | Standard anesthesia induction and propofol and remifentanil infusion were applied to group 1 patients with TIVA technique. Standard anesthesia induction and 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA were applied to group 2 patients with inhalation anesthesia technique |
postoperative 1 minute | |
Secondary | anesthetic consumption for group 2 N2O2 consumption (ml) and sevoflurane consumption (ml) | Standard anesthesia induction and 40% Oxygen 60% N2O2 and Sevoflurane at a concentration of 1.5-3.5% with 2 L / minTGA were applied to group 2 patients with inhalation anesthesia technique | postoperative 1 minute |
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