The Effects of Propofol and Thiopental on Nitric Oxide Production and Release in Erythrocytes

NCT ID: NCT06485388

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-07-07

Brief 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. 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.

Conditions

Effect of Drug

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Thiopental

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.

Group Type: ACTIVE_COMPARATOR

Thiopental

Intervention Type: DRUG

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.

Propofol

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

Thiopental

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.

Intervention Type: DRUG

Propofol

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Women patients
• ASA class >1
• Patients with known thiopental/propofol allergy
• Patients outside the age range of 18-45 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Melike Cengiz

OTHER

Sponsor Role: lead

Responsible Party

Melike Cengiz

MD,Professor Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulku Arslan Yildiz, MD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Pinar Ulker, PhD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University School of Medicine, Department of Physiology

Ahmet Yildirim

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University School of Medicine, Department of Physiology

Ayse Gulbin Arici, Professor

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University School of Medicine, Department of Anesthesiology and Reanimation, Turkey

Murat Yilmaz, Professor

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Locations

Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Akdeniz U. Faculty

Identifier Type: -

Identifier Source: org_study_id