Hypoxemia During SurgeryNCT04246567
Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
A study testing Mean Blood Pressure (MBP) and Add to 0.5 mcg / kg fentanyl. in people with Hypoxemia During Surgery and Hypoxia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypoxemia During Surgery, Hypoxia
- What is being tested?
- Mean Blood Pressure (MBP) and Add to 0.5 mcg / kg fentanyl.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-55 years old
- ASA Physical Status Classification System 1
- Undergoing to Elective rhinoplasty
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
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.
Read the 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
- Conditions
- Hypoxemia During Surgery, Hypoxia
- Being tested
- Mean Blood Pressure (MBP), Add to 0.5 mcg / kg fentanyl.
- Keywords
- hypotensive anesthesia, HIF 1a, total intravenous anesthesia, inhalation anesthesia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean Blood Pressure (MBP)Procedure or surgery
Mean blood pressure (MBP) for patients 50-65 mmHg
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Mean Blood Pressure (MBP); Drug: Add to 0.5 mcg / kg fentanyl. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline TOS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
Secondary outcomes (4)
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
Measured: postoperative 1 minute
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
Measured: postoperative 1 minute
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
Measured: postoperative 1 minute
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
Measured: postoperative 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Mar 2019
- Primary completion1 Sep 2019
- Study completionJan 2021 (estimated)
Why it stopped: Ethics approval is expected from the pharmaceutical institution for the study which has received the local ethics committee approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemia During SurgeryStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hayrettin Daşkaya, MD, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246567
- Sponsor's protocol ID
- Ayse02
- Status last verified
- May 2020
- First submitted
- 22 Jan 2020
- Last updated
- 11 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels
- ClinicalTrials.gov ID
- NCT04246567
- Acronym / sponsor ID
- Ayse02
- Conditions
- Hypoxemia During Surgery, Hypoxia
- Keywords
- hypotensive anesthesia, HIF 1a, total intravenous anesthesia, inhalation anesthesia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Ethics approval is expected from the pharmaceutical institution for the study which has received the local ethics committee approval.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia technique for group 1 patients | Active comparator | Procedure: Mean Blood Pressure (MBP), Drug: Add to 0.5 mcg / kg fentanyl.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 |
| Inhalation anesthesia technique for group 2 patients | Active comparator | Procedure: Mean Blood Pressure (MBP), Drug: Add to 0.5 mcg / kg fentanyl.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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-55 years old
- ASA Physical Status Classification System 1
- Undergoing to Elective rhinoplasty
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mean Blood Pressure (MBP)Mean blood pressure (MBP) for patients 50-65 mmHg | Procedure or surgery | Inhalation anesthesia technique for group 2 patients, Total intravenous anesthesia technique for group 1 patients |
| Add to 0.5 mcg / kg fentanyl.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. | Drug | Inhalation anesthesia technique for group 2 patients, Total intravenous anesthesia technique for group 1 patients |
Primary outcome
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by HIF1a
Time frame: Change from Baseline HIF 1a 30th minute (t1), 1st hour (t2) and 2st hour (t3)
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.
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TAS
Time frame: Change from Baseline TAS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
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.
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by the concentration of TOS
Time frame: Change from Baseline TOS levels at 30th minute (t1), 1st hour (t2) and 2st hour (t3)
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.
4 secondary outcomes
surgical satisfaction
Time frame: postoperative 1 minute
bleeding scores
Time frame: postoperative 1 minute
anesthetic consumption for group 1 propofol consumption (mg) and remifentanyl consumption(microgram)
Time frame: postoperative 1 minute
anesthetic consumption for group 2 N2O2 consumption (ml) and sevoflurane consumption (ml)
Time frame: postoperative 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
Related trials for Hypoxemia During Surgery
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruiting
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
Hypoxemia During Surgery
Not yet recruiting
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Elderly Patients, Laparoscopic Surgery
Recruiting
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
Hypoxemia During Surgery
Enrolling by invitationObservational study
Spontaneous Breathing Mode: A Risk for Hypoxemia During OLV?
Lung Cancer, OLV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayrettin Daşkaya, MD study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mean Blood Pressure (MBP) and Add to 0.5 mcg / kg fentanyl. in people with Hypoxemia During Surgery and Hypoxia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the relationship between hypotensive anesthesia technique and tissue hypoxia by HIF1a (time frame: Change from Baseline HIF 1a 30th minute (t1), 1st hour (t2) and 2st hour (t3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.