A Phase 4 interventional study of paracetamol (acetaminophen) solution commercial in Oxidative Stress and Sevoflurane Anaesthesia, sponsored by University of Belgrade. Completed at 1 site in Serbia. Open to participants aged 2 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Belgrade · Phase 4, Interventional, and Basic science
This study investigated the effects of paracetamol administration on oxidative stress in children undergoing inguinal hernia surgery under sevoflurane-based general anesthesia.
Oxidative stress occurs when the production of potentially harmful molecules exceeds the body's antioxidant defenses. Anesthesia and surgery may influence this balance.
The study compared two groups of children who received intravenous paracetamol at different stages of anesthesia. In one group, paracetamol was administered before premedication with midazolam and induction of anesthesia with sevoflurane. In the other group, paracetamol was administered after midazolam premedication and induction of anesthesia.
Blood samples were collected at four predefined time points to measure markers of oxidative stress and antioxidant defense.
The aim was to determine whether the timing of paracetamol administration influenced oxidative stress parameters in children undergoing surgery.
This interventional study was conducted as part of a doctoral research project to investigate the effects of paracetamol administration timing on oxidative stress in pediatric patients undergoing inguinal hernia surgery under sevoflurane-based general anesthesia.
Background and Rationale
Oxidative stress results from an imbalance between the production of reactive oxygen species and the body's antioxidant defense mechanisms. General anesthesia and surgical procedures may affect oxidative balance. Paracetamol is widely used for perioperative analgesia and has been investigated for its potential effects on oxidative processes.
Study Procedures
The study included two groups of pediatric patients who received intravenous paracetamol at different stages of the anesthetic procedure.
In the first group (PS), paracetamol was administered before midazolam premedication and induction of anesthesia with sevoflurane.
In the second group (SP), midazolam premedication and induction of anesthesia with sevoflurane preceded paracetamol administration.
Anesthesia was induced with sevoflurane, followed by administration of the medications required for airway management and maintenance of general anesthesia.
Blood samples were collected at four predefined time points according to the study protocol.
Biochemical Assessment
Oxidative stress and antioxidant defense were assessed using the following biochemical parameters:
Erythrocyte antioxidant enzyme activities: superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx), and glutathione reductase (GR).
Plasma parameters: malondialdehyde (MDA), sulfhydryl (SH) groups, total glutathione, superoxide dismutase (SOD), and nitric oxide metabolites (NOx).
Study Objective
The objective was to evaluate changes in oxidative stress parameters during the perioperative period and to determine whether the timing of paracetamol administration influenced these changes in children undergoing sevoflurane-based anesthesia.
University of Belgrade is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Previous use of multivitamin preparations or dietary supplements.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received intravenous paracetamol before midazolam premedication and induction of general anesthesia with sevoflurane. Oxidative stress parameters were assessed at four predefined sampling time points.
Drug: paracetamol (acetaminophen) solution commercial
Participants received intravenous paracetamol after midazolam premedication and induction of general anesthesia with sevoflurane. Oxidative stress parameters were assessed at four predefined sampling time points.
Drug: paracetamol (acetaminophen) solution commercial
Intravenous paracetamol (10 mg/mL formulation) was administered over 15 minutes. In the PS group, paracetamol was administered before midazolam premedication and induction of anesthesia with sevoflurane. In the SP group, paracetamol was administered after midazolam premedication and induction of anesthesia with sevoflurane. Both groups underwent sevoflurane-based general anesthesia according to the same anesthetic protocol. The intervention under investigation was the timing of paracetamol administration in relation to premedication and anesthetic induction.
Change in Erythrocyte Superoxide Dismutase (SOD) Activity
Erythrocyte superoxide dismutase (SOD) activity was measured spectrophotometrically and expressed in U/g Hb. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision
Change in Erythrocyte Catalase (CAT) Activity
Erythrocyte catalase (CAT) activity was measured spectrophotometrically as an indicator of antioxidant defense. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Erythrocyte Glutathione Peroxidase (GPx) Activity
Erythrocyte glutathione peroxidase (GPx) activity was measured spectrophotometrically as an indicator of enzymatic antioxidant defense. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Erythrocyte Glutathione Reductase (GR) Activity
Erythrocyte glutathione reductase (GR) activity was measured spectrophotometrically as an indicator of enzymatic antioxidant defense. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Plasma Malondialdehyde (MDA) Concentration
Plasma malondialdehyde (MDA) concentration was measured as a marker of lipid peroxidation and oxidative stress. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Plasma Total Sulfhydryl (SH) Group Levels
Plasma total sulfhydryl (SH) group levels were measured using a spectrophotometric method based on 5,5'-dithiobis-(2-nitrobenzoic acid) (DTNB) as an indicator of plasma antioxidant status. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Plasma Total Glutathione Concentration
Plasma total glutathione concentration was measured as an indicator of antioxidant defense and redox homeostasis. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Plasma Superoxide Dismutase (SOD) Activity
Plasma superoxide dismutase (SOD) activity was measured as an indicator of extracellular antioxidant defense. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Change in Plasma Nitric Oxide Metabolite (NOx) Concentration
Plasma nitric oxide metabolites (NOx), comprising nitrite and nitrate, were measured using the Griess reaction following nitrate reduction. Changes across four predefined blood sampling points were evaluated and compared between the two paracetamol administration groups.
Time frame: Four perioperative sampling points, from baseline to the final blood sample before surgical incision.
Plan to share: No — Individual participant data will not be shared because the study involved pediatric patients and data sharing was not included in the original study protocol or informed consent process. Study results will be reported in aggregate form to protect participant confidentiality.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Acetaminophen
University of Belgrade