A Phase 4 interventional study of Spinal Anesthesia and Propofol in Oxidative Stress and Cesarean Section, sponsored by University of Banja Luka. Completed at 1 site in Bosnia and Herzegovina. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Banja Luka · Phase 4, Interventional, and Basic science
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Oxidative stress occurs when the production of reactive molecules exceeds the body's antioxidant defenses. Pregnancy is associated with physiological changes that may increase oxidative stress in both the mother and fetus. The type of anesthesia used during cesarean delivery may influence this process.
This study aimed to investigate whether general anesthesia using target-controlled infusion (TCI) of propofol affects maternal and fetal oxidative stress compared with spinal anesthesia and general anesthesia using thiopental and sevoflurane.
A total of 90 healthy pregnant women undergoing elective cesarean delivery were included in this prospective study. Participants were divided into three groups of 30: spinal anesthesia, propofol-based general anesthesia, and thiopental-sevoflurane general anesthesia.
Maternal venous blood, umbilical venous blood, and placental tissue samples were collected to assess biochemical markers of oxidative stress and antioxidant defense. Clinical and anesthesia-related data were also recorded.
The study was designed to compare oxidative stress markers across the three anesthesia techniques and evaluate the potential antioxidant effects of propofol on the mother and fetus.
This prospective, open-label clinical study was conducted at the University Clinical Centre of the Republic of Srpska in Banja Luka, Bosnia and Herzegovina, to investigate the effects of different anesthetic techniques on maternal and fetal oxidative stress during elective cesarean delivery.
The study included 90 pregnant women with uncomplicated pregnancies undergoing elective cesarean delivery. Participants were allocated to three groups of 30 according to the anesthetic technique: spinal anesthesia (Group S), general anesthesia with target-controlled infusion of propofol (Group P), and general anesthesia with thiopental induction followed by sevoflurane maintenance (Group TS).
Maternal venous blood, umbilical venous blood, and placental tissue samples were collected to assess oxidative stress and antioxidant defense mechanisms. The biochemical analyses included markers of lipid peroxidation, reactive oxygen species, and antioxidant activity, including thiobarbituric acid-reactive substances (TBARS), nitrites, hydrogen peroxide, superoxide anion, superoxide dismutase (SOD), reduced glutathione (GSH), and catalase (CAT).
Maternal hemodynamic parameters, anesthetic drug administration, neonatal clinical outcomes, and postoperative maternal outcomes were also evaluated.
The study aimed to compare oxidative stress responses across the three anesthetic techniques and investigate whether propofol-based total intravenous anesthesia provides potential antioxidant benefits in the maternal-placental-fetal system.
University of Banja Luka is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thirty women undergoing elective cesarean section under spinal anesthesia.
Procedure: Spinal Anesthesia
Thirty women undergoing elective cesarean section under general anesthesia using target-controlled infusion of propofol.
Drug: Propofol
Thirty women undergoing elective cesarean section under general anesthesia with thiopental induction and sevoflurane maintenance.
Drug: Thiopental · Drug: Sevoflurane
Spinal anesthesia administered for elective cesarean section as part of routine clinical care.
General anesthesia using target-controlled infusion of propofol for elective cesarean section.
Thiopental was administered intravenously for induction of general anesthesia in women undergoing elective cesarean section. Anesthesia was subsequently maintained with sevoflurane.
Sevoflurane was administered by inhalation for maintenance of general anesthesia during elective cesarean section, following intravenous induction with thiopental.
Maternal Plasma TBARS Concentration
Thiobarbituric acid-reactive substances (TBARS), an indicator of lipid peroxidation, measured in maternal plasma. Concentrations were compared across the three anesthesia groups and assessed at three perioperative time points. Values are expressed in mmol/L.
Time frame: Before anesthesia, during cesarean delivery, and 2 hours postoperatively.
Umbilical Cord Venous Plasma TBARS Concentration
Thiobarbituric acid-reactive substances (TBARS), an indicator of lipid peroxidation, measured in umbilical cord venous plasma. Concentrations were compared across the three anesthesia groups. Values are expressed in mmol/L.
Time frame: At delivery (umbilical cord venous blood sampling).
Placental Tissue TBARS Concentration
Thiobarbituric acid-reactive substances (TBARS), an indicator of lipid peroxidation, measured in placental tissue homogenates. Concentrations were compared across the three anesthesia groups. Values are expressed in µmol/g of tissue.
Time frame: At delivery, immediately following placental removal.
Maternal Plasma Hydrogen Peroxide (H2O2) Concentration
Hydrogen peroxide (H2O2), a marker of oxidative stress, measured in maternal plasma. Concentrations were compared across the three anesthesia groups at three perioperative time points. Values are expressed in nmol/mL.
Time frame: Before anesthesia, after delivery and placental removal, and 2 hours postoperatively.
Umbilical Cord Venous Plasma Hydrogen Peroxide (H2O2) Concentration
Hydrogen peroxide (H2O2), a marker of oxidative stress, measured in umbilical cord venous plasma. Concentrations were compared across the three anesthesia groups. Values are expressed in nmol/mL.
Time frame: At delivery (umbilical cord venous blood sampling).
Maternal Plasma Superoxide Anion (O2-) Concentration
Superoxide anion (O2-), a reactive oxygen species and marker of oxidative stress, measured in maternal plasma. Concentrations were compared across the three anesthesia groups at three perioperative time points. Values are expressed in nmol/mL.
Time frame: Before anesthesia, after delivery and placental removal, and 2 hours postoperatively.
Umbilical Cord Venous Plasma Superoxide Anion (O2-) Concentration
Superoxide anion (O2-), a reactive oxygen species and marker of oxidative stress, measured in umbilical cord venous plasma. Concentrations were compared across the three anesthesia groups. Values are expressed in nmol/mL.
Time frame: At delivery (umbilical cord venous blood sampling).
Maternal Plasma Nitrite (NO2-) Concentration
Nitrite (NO2-), an indicator of nitric oxide metabolism, measured in maternal plasma. Concentrations were compared across the three anesthesia groups at three perioperative time points. Values are expressed in nmol/mL.
Time frame: Before anesthesia, after delivery and placental removal, and 2 hours postoperatively.
Umbilical Cord Venous Plasma Nitrite (NO2-) Concentration
Nitrite (NO2-), an indicator of nitric oxide metabolism, measured in umbilical cord venous plasma. Concentrations were compared across the three anesthesia groups. Values are expressed in nmol/mL.
Time frame: At delivery (umbilical cord venous blood sampling).
Maternal Erythrocyte Superoxide Dismutase (SOD) Activity
Superoxide dismutase (SOD) activity, an indicator of enzymatic antioxidant defense, measured in maternal erythrocyte lysates. Activity was compared across the three anesthesia groups at three perioperative time points. Values are expressed in U/g Hgb × 10³.
Time frame: Before anesthesia, after delivery and placental removal, and 2 hours postoperatively.
Umbilical Cord Venous Erythrocyte Superoxide Dismutase (SOD) Activity
Superoxide dismutase (SOD) activity, an indicator of enzymatic antioxidant defense, measured in erythrocyte lysates from umbilical cord venous blood. Activity was compared across the three anesthesia groups. Values are expressed in U/g Hgb × 10³.
Time frame: At delivery (umbilical cord venous blood sampling).
Placental Tissue Superoxide Dismutase (SOD) Activity
Superoxide dismutase (SOD) activity, an indicator of enzymatic antioxidant defense, measured in placental tissue homogenates. Activity was compared across the three anesthesia groups. Values are expressed in U/g of tissue.
Time frame: At delivery, following placental removal.
Maternal Erythrocyte Reduced Glutathione (GSH) Concentration
Reduced glutathione (GSH), a non-enzymatic antioxidant involved in cellular defense against oxidative stress, measured in maternal erythrocyte lysates. Concentrations were compared across the three anesthesia groups at three perioperative time points. Values are expressed in nmol/mL RBC.
Time frame: Before anesthesia, after delivery and placental removal, and 2 hours postoperatively.
Umbilical Cord Venous Erythrocyte Reduced Glutathione (GSH) Concentration
Reduced glutathione (GSH), a non-enzymatic antioxidant involved in cellular defense against oxidative stress, measured in erythrocyte lysates from umbilical cord venous blood. Concentrations were compared across the three anesthesia groups. Values are expressed in nmol/mL RBC.
Time frame: At delivery (umbilical cord venous blood sampling).
Placental Tissue Reduced Glutathione (GSH) Concentration
Reduced glutathione (GSH), a non-enzymatic antioxidant involved in cellular defense against oxidative stress, measured in placental tissue homogenates. Concentrations were compared across the three anesthesia groups. Values are expressed in nmol/g of tissue.
Time frame: At delivery, following placental removal.
Maternal Erythrocyte Catalase (CAT) Activity
Catalase (CAT) activity, an indicator of enzymatic antioxidant defense, measured in maternal erythrocyte lysates. Activity was compared across the three anesthesia groups at three perioperative time points. Values are expressed in U/g Hgb × 10³.
Time frame: Before anesthesia, after delivery and placental removal, and 2 hours postoperatively.
Umbilical Cord Venous Erythrocyte Catalase (CAT) Activity
Catalase (CAT) activity, an indicator of enzymatic antioxidant defense, measured in erythrocyte lysates from umbilical cord venous blood. Activity was compared across the three anesthesia groups. Values are expressed in U/g Hgb × 10³.
Time frame: At delivery (umbilical cord venous blood sampling).
Placental Tissue Catalase (CAT) Activity
Catalase (CAT) activity, an indicator of enzymatic antioxidant defense, measured in placental tissue homogenates. Activity was compared across the three anesthesia groups. Values are expressed in U/g of tissue.
Time frame: At delivery, following placental removal.
Umbilical Cord Blood pH
Umbilical cord blood pH measured by blood gas analysis immediately after delivery to assess neonatal acid-base status. Values were compared across the three anesthesia groups. pH is dimensionless.
Time frame: At delivery (umbilical cord blood sampling).
Umbilical Cord Blood Partial Pressure of Oxygen (pO₂)
Partial pressure of oxygen (pO₂) measured in umbilical cord blood by blood gas analysis to assess neonatal oxygenation at birth. Values were compared across the three anesthesia groups. Results are expressed in mmHg.
Time frame: At delivery (umbilical cord blood sampling).
Umbilical Cord Blood Partial Pressure of Carbon Dioxide (pCO₂)
Partial pressure of carbon dioxide (pCO₂) measured in umbilical cord blood by blood gas analysis to assess neonatal acid-base status at birth. Values were compared across the three anesthesia groups. Results are expressed in mmHg.
Time frame: At delivery (umbilical cord blood sampling).
Umbilical Cord Blood Base Excess (BE)
Base excess (BE) measured in umbilical cord blood by blood gas analysis to assess neonatal metabolic acid-base status at birth. Values were compared across the three anesthesia groups. Results are expressed in mmol/L.
Time frame: At delivery (umbilical cord blood sampling).
Umbilical Cord Blood Lactate Concentration
Lactate concentration measured in umbilical cord blood by blood gas analysis to assess neonatal metabolic status at birth. Values were compared across the three anesthesia groups. Results are expressed in mmol/L.
Time frame: At delivery (umbilical cord blood sampling).
Maternal Venous Blood pH
Maternal venous blood pH measured by blood gas analysis during cesarean delivery to assess maternal acid-base status. Values were compared across the three anesthesia groups. pH is dimensionless.
Time frame: Intraoperatively, during cesarean delivery.
Maternal Venous Blood Partial Pressure of Oxygen (pO₂)
Partial pressure of oxygen (pO₂) measured in maternal venous blood by blood gas analysis during cesarean delivery to assess maternal venous oxygenation. Values were compared across the three anesthesia groups. Results are expressed in mmHg.
Time frame: Intraoperatively, during cesarean delivery.
Maternal Venous Blood Partial Pressure of Carbon Dioxide (pCO₂)
Partial pressure of carbon dioxide (pCO₂) measured in maternal venous blood by blood gas analysis during cesarean delivery to assess maternal acid-base and respiratory status. Values were compared across the three anesthesia groups. Results are expressed in mmHg.
Time frame: Intraoperatively, during cesarean delivery.
Intraoperatively, during cesarean delivery.
Lactate concentration measured in maternal venous blood by blood gas analysis during cesarean delivery to assess maternal metabolic status. Values were compared across the three anesthesia groups. Results are expressed in mmol/L.
Time frame: Intraoperatively, during cesarean delivery.
Maternal Venous Blood Base Excess (BE)
Base excess (BE) measured in maternal venous blood by blood gas analysis during cesarean delivery to assess maternal metabolic acid-base status. Values were compared across the three anesthesia groups. Results are expressed in mmol/L.
Time frame: Intraoperatively, during cesarean delivery.
Maternal White Blood Cell Count (WBC)
Maternal white blood cell (WBC) count measured in venous blood as part of a complete blood count to assess maternal hematological status. Values were compared across the three anesthesia groups. Results are expressed in ×10⁹/L.
Time frame: Intraoperatively and 2 hours after delivery.
Maternal C-Reactive Protein (CRP) Concentration
Maternal C-reactive protein (CRP) concentration measured in venous blood to assess maternal inflammatory status. Values were compared across the three anesthesia groups. Results are expressed in mg/L.
Time frame: Intraoperatively and 2 hours after delivery.
Intraoperatively and 2 hours after delivery.
Neonatal white blood cell (WBC) count measured in venous blood as part of a complete blood count to assess neonatal hematological status. Values were compared across the three maternal anesthesia groups. Results are expressed in ×10⁹/L.
Time frame: 48-72 hours after birth.
Neonatal C-Reactive Protein (CRP) Concentration
Neonatal C-reactive protein (CRP) concentration measured in venous blood to assess neonatal inflammatory status. Values were compared across the three maternal anesthesia groups. Results are expressed in mg/L.
Time frame: 48-72 hours after birth.
Maternal Mean Arterial Pressure (MAP)
Maternal mean arterial pressure (MAP) was calculated from noninvasively measured systolic and diastolic arterial blood pressure values. Measurements were obtained before anesthesia and at 2-minute intervals after anesthesia initiation. MAP values were compared across the three anesthesia groups and expressed in mmHg.
Time frame: Before anesthesia (minute 0) and at 2, 4, 6, 8, and 10 minutes after anesthesia initiation, until delivery.
Maternal Heart Rate (HR)
Maternal heart rate (HR) measured by standard intraoperative monitoring before anesthesia and at 2-minute intervals after anesthesia initiation. Measurements were compared across the three anesthesia groups. Results are expressed in beats per minute (bpm).
Time frame: Before anesthesia (minute 0) and at 2, 4, 6, 8, and 10 minutes after anesthesia initiation.
Patient-Reported Anesthesia-Related Adverse Effects
Anesthesia-related adverse effects were assessed using the Bauer questionnaire on the first postoperative day. Ten symptoms were evaluated: postoperative pain, drowsiness, thirst, hoarseness, sore throat, nausea and vomiting, feeling cold, difficulty concentrating, pain at the anesthetic administration site, and shivering. The outcome was expressed as the number and percentage of patients reporting each adverse effect, separately for each anesthesia group.
Time frame: On the first postoperative day (24 hours after anesthesia).
Intraoperative Awareness During General Anesthesia
Intraoperative awareness was assessed in patients receiving general anesthesia using the modified Brice questionnaire. Patients were asked about their last memory before anesthesia, first memory after awakening, any recollection of events during surgery, and dreams during anesthesia. The occurrence of reported intraoperative awareness was compared between the propofol TCI and thiopental-sevoflurane groups. The outcome was expressed as the number and percentage of patients reporting intraoperative awareness.
Time frame: On the first postoperative day (24 hours after anesthesia).
Neonatal Apgar Score at 1 Minute
Neonatal condition was assessed using the Apgar score at 1 minute after birth. The score evaluates five components: heart rate, respiratory effort, muscle tone, reflex irritability, and skin color. Each component is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Apgar scores were compared across the three maternal anesthesia groups. Higher Apgar scores indicate better neonatal clinical condition.
Time frame: 1 minute after birth.
Neonatal Apgar Score at 5 Minutes
Neonatal condition was assessed using the Apgar score at 5 minutes after birth. The score evaluates five components: heart rate, respiratory effort, muscle tone, reflex irritability, and skin color. Each component is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Apgar scores were compared across the three maternal anesthesia groups. Higher Apgar scores indicate better neonatal clinical condition.
Time frame: 5 minutes after birth.
Plan to share: No — Individual participant data will not be shared because data sharing was not included in the original study protocol or informed consent procedures.
Ran from Nov 2022 to primary completion in Feb 2024, 15 months.
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Studies of the drug tested here: Propofol
University of Banja Luka