Effect of DrugNCT06485388
The Effects of Propofol and Thiopental on Nitric Oxide Production and Release in Erythrocytes
A study testing Propofol and Thiopental in people with Effect of Drug, run by Melike Cengiz at 1 site in Turkey (Türkiye).
Trial summary
Hypotension is frequently encountered during the use of these commonly used intravenous anaesthetic agents (thiopental and propofol). This is thought to be a consequence of their effects on the sympathetic nervous system, myocardial contractility or vascular tone. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Propofol and Thiopental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 7 Jul 2024
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients
- Aged 18-45 years
- ASA (American Society of Anaesthesiologists) class I (normal, healthy person without any disease or systemic problem other than surgical pathology that does not cause a systemic disorder)
Who cannot join
- Women patients
- ASA class >1
- Patients with known thiopental/propofol allergy
- Patients outside the age range of 18-45 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Antalya
About this study
Hypotension is frequently encountered during the use of these commonly used intravenous anaesthetic agents (thiopental and propofol). This is thought to be a consequence of their effects on the sympathetic nervous system, myocardial contractility or vascular tone. However, propofol causes a greater fall in systemic arterial blood pressure than any other drug used for induction of anaesthesia. Propofol causes profound vasodilation, whereas its myocardial depressant effect is not clear. The vasodilatation occurs in both arterial and venous systems. The decrease in systemic arterial blood pressure after thiopental induction is mainly due to peripheral vasodilatation caused by depression of the medullary vasomotor centre and inhibition of the sympathetic nervous system. However, how this peripheral vasodilator effect occurs after both drugs and which mediators accompany it have not yet been fully elucidated. In previous studies, it has been emphasised that systemic vasodilation may be related with increased formation of nitric oxide (NO), a small gaseous and lipophilic molecule which plays an important role in the regulation of vascular homeostasis and haemoregulation. It is important to elucidate the mechanisms that may mediate thiopental- and propofol-mediated vasodilatation in future studies in order to help the methods and treatments that can be developed to prevent hypotension caused by these drugs, which are widely used in clinical practice. Therefore, the aim of this study was to investigate the effects of thiopental and profol on erythrocyte NO synthase activity and erythrocyte-mediated NO release.
Read the detailed description
Male patients aged 18-45 years with ASA (American Society of Anaesthesiologists) class I (normal, healthy person without any disease or systemic problem other than surgical pathology that does not cause a systemic disorder) who applied to the anaesthesiology and reanimation clinic outpatient clinic for preoperative preparation were planned to be included in the study. Women, patients with ASA class >1, patients with known thiopental/propofol allergy and patients outside the age range of 18-45 years were excluded from the study. Venous blood samples will be taken from the patients included in the study and incubated with thiopental and propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release.All patients included in the study will be informed and their written and verbal consent will be obtained.
- Conditions
- Effect of Drug
- Being tested
- Propofol, Thiopental
- Keywords
- nitric oxide, erythrocyte, propofol, thiopental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Venous blood samples will be taken from the patients included in the study and incubated with propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release.
ThiopentalDrug
Venous blood samples will be taken from the patients included in the study and incubated with thiopental (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release.
| Study group | Role | What they receive |
|---|---|---|
| Thiopental | Active comparator | Venous blood samples will be taken from the patients included in the study and incubated with thiopental (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release. Receives: Drug: Thiopental |
| Propofol | Active comparator | Venous blood samples will be taken from the patients included in the study and incubated with propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of thiopental and propofol on erythrocyte NO synthase activity and erythrocyte-mediated NO release.
Blood samples will be taken from healthy human volunteers aged 25-45 years. Measurements will be performed using the fluorescent NO probe 4-amino-5-methylamino-20,70-difluorofluorescein diacetate. Propofol and thiopental will be added to the suspensions at doses of 100, 250, 500 and 1000 µM and incubated for 30 minutes. We will repeate these experiments in the presence of L-NAME, a non-specific nitric oxide synthase inhibitor. The nitrite/nitrate concentration will be measured in the supernatant of the erythrocyte suspensions after centrifugation.Intracellular calcium measurements will also be made during propofol and thiopental experiments. Fluo-4 calcium dye will be added to the medium and flow cytometric measurements will be repeated.
Measured: 120 days
Secondary outcomes (1)
The effects of thiopental and propofol on erythrocyte haemorheology
The effects of thiopental and propofol on erythrocyte haemorheology. Blood samples will be taken from healthy male volunteers and leucocytes will be extracted. The RBC deformability will be measured as an elongation index (EI) for various liquid shear stresses by laser diffraction analysis using an ectacytometer (LORRCA, RR Mechatronics, Hoorn, The Netherlands).RBC aggregation will be assessed using the same echacytometer. Aggregation will be determined by placing 1 ml of blood in the space between the cup and bob. The sample will then be sheared at a speed of 800 1/s for 10 seconds to disperse pre-existing aggregates. After 10 seconds, the shear will be abruptly reduced to zero and the level of laser light reflected from the sample will be digitally recorded for 120 seconds.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Cengiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melike Cengiz, Akdeniz University
- Investigators
- Ulku Arslan Yildiz, MD, Principal investigator, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, TurkeyPinar Ulker, PhD, Principal investigator, Akdeniz University School of Medicine, Department of PhysiologyAhmet Yildirim, Principal investigator, Akdeniz University School of Medicine, Department of PhysiologyAyse Gulbin Arici, Professor, Principal investigator, Akdeniz University School of Medicine, Department of Anesthesiology and Reanimation, TurkeyMurat Yilmaz, Professor, Principal investigator, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485388
- Sponsor's protocol ID
- Akdeniz U. Faculty
- Status last verified
- Jul 2024
- First submitted
- 17 Mar 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Propofol and Thiopental on Nitric Oxide Production and Release in Erythrocytes
- ClinicalTrials.gov ID
- NCT06485388
- Acronym / sponsor ID
- Akdeniz U. Faculty
- Conditions
- Effect of Drug
- Keywords
- nitric oxide, erythrocyte, propofol, thiopental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Melike CengizUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 3 Jul 2024 (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.
Hypotension is frequently encountered during the use of these commonly used intravenous anaesthetic agents (thiopental and propofol). This is thought to be a consequence of their effects on the sympathetic nervous system, myocardial contractility or vascular tone. However, propofol causes a greater fall in systemic arterial blood pressure than any other drug used for induction of anaesthesia. Propofol causes profound vasodilation, whereas its myocardial depressant effect is not clear. The vasodilatation occurs in both arterial and venous systems. The decrease in systemic arterial blood pressure after thiopental induction is mainly due to peripheral vasodilatation caused by depression of the medullary vasomotor centre and inhibition of the sympathetic nervous system. However, how this peripheral vasodilator effect occurs after both drugs and which mediators accompany it have not yet been fully elucidated. In previous studies, it has been emphasised that systemic vasodilation may be related with increased formation of nitric oxide (NO), a small gaseous and lipophilic molecule which plays an important role in the regulation of vascular homeostasis and haemoregulation. It is important to elucidate the mechanisms that may mediate thiopental- and propofol-mediated vasodilatation in future studies in order to help the methods and treatments that can be developed to prevent hypotension caused by these drugs, which are widely used in clinical practice. Therefore, the aim of this study was to investigate the effects of thiopental and profol on erythrocyte NO synthase activity and erythrocyte-mediated NO release.
Detailed description
Male patients aged 18-45 years with ASA (American Society of Anaesthesiologists) class I (normal, healthy person without any disease or systemic problem other than surgical pathology that does not cause a systemic disorder) who applied to the anaesthesiology and reanimation clinic outpatient clinic for preoperative preparation were planned to be included in the study. Women, patients with ASA class >1, patients with known thiopental/propofol allergy and patients outside the age range of 18-45 years were excluded from the study. Venous blood samples will be taken from the patients included in the study and incubated with thiopental and propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release.All patients included in the study will be informed and their written and verbal consent will be obtained.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiopental | Active comparator | Drug: ThiopentalVenous blood samples will be taken from the patients included in the study and incubated with thiopental (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release. |
| Propofol | Active comparator | Drug: PropofolVenous blood samples will be taken from the patients included in the study and incubated with propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male patients
- Aged 18-45 years
- ASA (American Society of Anaesthesiologists) class I (normal, healthy person without any disease or systemic problem other than surgical pathology that does not cause a systemic disorder)
Key exclusion criteria (4 listed)
- Women patients
- ASA class >1
- Patients with known thiopental/propofol allergy
- Patients outside the age range of 18-45 years
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 |
|---|---|---|
| PropofolVenous blood samples will be taken from the patients included in the study and incubated with propofol (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release. | Drug | Propofol |
| ThiopentalVenous blood samples will be taken from the patients included in the study and incubated with thiopental (dose: 100, 250, 500 and 1000µM) after appropriate procedures in the laboratory environment. . After incubation, all resuspensions will be subjected to flow cytometric analysis to evaluate erythrocyte NO synthase activity and erythrocyte-mediated NO release. | Drug | Thiopental |
Primary outcome
The effects of thiopental and propofol on erythrocyte NO synthase activity and erythrocyte-mediated NO release.
Time frame: 120 days
Blood samples will be taken from healthy human volunteers aged 25-45 years. Measurements will be performed using the fluorescent NO probe 4-amino-5-methylamino-20,70-difluorofluorescein diacetate. Propofol and thiopental will be added to the suspensions at doses of 100, 250, 500 and 1000 µM and incubated for 30 minutes. We will repeate these experiments in the presence of L-NAME, a non-specific nitric oxide synthase inhibitor. The nitrite/nitrate concentration will be measured in the supernatant of the erythrocyte suspensions after centrifugation.Intracellular calcium measurements will also be made during propofol and thiopental experiments. Fluo-4 calcium dye will be added to the medium and flow cytometric measurements will be repeated.
1 secondary outcome
The effects of thiopental and propofol on erythrocyte haemorheology
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Ulku Arslan Yildiz, MD principal investigator
Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Pinar Ulker, PhD principal investigator
Akdeniz University School of Medicine, Department of Physiology
Ahmet Yildirim principal investigator
Akdeniz University School of Medicine, Department of Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Thiopental in people with Effect of Drug, run by Melike Cengiz 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 4 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: finished, as of the sponsor's last update on 1 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effects of thiopental and propofol on erythrocyte NO synthase activity and erythrocyte-mediated NO release. (time frame: 120 days). 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 1 Aug 2024.