Clinical trials

Prenatal exposure to tobacco smoke, through either active maternal smoking or secondhand exposure, has been associated with impaired fetal oxygenation, metabolic stress, and adverse early neonatal outcomes. This prospective, single-center observational cohort study will objectively assess maternal tobacco exposure using cotinine measured in maternal urine and examine its association with early neonatal biochemical, metabolic, and clinical outcomes. Consecutive eligible mother-newborn dyads will be recruited at a tertiary academic hospital after written informed consent is obtained. A clean-catch midstream maternal urine sample will be collected within 24 hours before delivery, preferably at admission to the delivery unit and before intravenous fluid administration, for quantitative cotinine and creatinine measurement. Maternal tobacco exposure will be assessed using the urinary cotinine concentration, the cotinine-to-creatinine ratio, and maternal self-reported smoking and secondhand smoke exposure. Based on prespecified biomarker thresholds and exposure history, participants will be classified as having active exposure, passive exposure, or no exposure. No experimental intervention will be administered. Neonatal data will include umbilical cord blood gas parameters, including pH, pCO2, pO2, base excess, bicarbonate, lactate, and fetal carboxyhemoglobin (FCOHb). Birthweight, length, head circumference, Apgar scores, oxygen saturation, heart rate, and blood pressure will also be recorded. Routine laboratory measurements obtained during the early postnatal period will include complete blood count parameters, hematologic and inflammatory indices such as NLR and PLR, albumin, the albumin-to-lactate ratio, HDL, LDL, and other routinely available biochemical markers. Thyroid-stimulating hormone results from the national newborn screening program and newborn hearing screening results will be recorded. Postnatal weight loss and bilirubin measurements from routine follow-up visits will also be collected when available. The primary objective is to determine whether increasing maternal urinary cotinine exposure is associated with higher umbilical cord blood lactate and FCOHb levels, indicating greater metabolic stress and impaired fetal oxygenation. Secondary objectives include evaluating associations with cord blood gas parameters, birthweight, early hematologic and biochemical indices, albumin and the albumin-to-lactate ratio, blood pressure, bilirubin levels, thyroid screening results, and hearing screening outcomes. Maternal, obstetric, and perinatal variables, including maternal age, parity, gestational age, mode of delivery, smoking history, intrapartum factors, and relevant maternal comorbidities, will be recorded for adjusted analyses. Statistical analyses will include comparisons among the three exposure groups and multivariable regression models evaluating urinary cotinine both as a continuous measure and as a categorical exposure variable. This study is designed to provide prospectively collected, biomarker-verified evidence regarding the relationship between maternal tobacco exposure and immediate neonatal metabolic, hematologic, and physiologic outcomes using measurements that are feasible within routine clinical care.

\## Brief Summary Neonatal hyperbilirubinemia is one of the most common causes of neonatal hospitalization and phototherapy treatment. Although phototherapy is highly effective, rebound hyperbilirubinemia following discontinuation of phototherapy may occur in some infants and may require repeat treatment. Early identification of neonates at risk for clinically significant rebound hyperbilirubinemia could help optimize discharge timing and reduce unnecessary hospital stay and repeat bilirubin testing. This prospective observational study aims to evaluate the predictors of rebound hyperbilirubinemia after phototherapy discontinuation in neonates admitted to the NICU. Particular focus will be placed on the role of delta total serum bilirubin (ΔTSB), defined as the difference between the phototherapy threshold and the measured bilirubin level at the time of phototherapy discontinuation. Clinical, demographic, laboratory, hemolytic, feeding-related, and phototherapy-related variables will also be analyzed. The primary outcome will be clinically significant rebound hyperbilirubinemia requiring repeat phototherapy within 24-48 hours after discontinuation of the initial phototherapy treatment. Secondary outcomes include rebound bilirubin levels, duration of hospitalization, and factors associated with repeat phototherapy.

This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. In routine clinical practice, dexamethasone may be administered orally, intravenously, or not administered, depending on the surgeon's established perioperative protocol. The primary objective is to assess early postoperative recovery in terms of pain intensity, functional mobility, and knee joint range of motion. Secondary objectives include evaluation of inflammatory response, postoperative metabolic changes, opioid requirement, and the severity of postoperative nausea and vomiting (PONV). Group allocation is non-randomized and determined solely by the standard perioperative management approach routinely applied by the surgeon selected by the patient. No additional interventions are introduced for research purposes. All outcomes are assessed prospectively during the early postoperative period.

The goal of this observational study is to learn how the length of pneumoperitoneum during laparoscopic inguinal hernia surgery may affect changes in blood bicarbonate levels. Pneumoperitoneum is the use of carbon dioxide gas to create space inside the abdomen during laparoscopic surgery. The main question this study aims to answer is whether a longer pneumoperitoneum time is associated with changes in blood bicarbonate levels after surgery. Participants are adults undergoing laparoscopic inguinal hernia repair as part of their routine medical care. Researchers will measure blood gas values, including bicarbonate levels, before surgery and again two hours after surgery. The change in bicarbonate levels will be compared with the duration of pneumoperitoneum during the operation. The results of this study may help improve the understanding of metabolic changes that occur during laparoscopic surgery.

Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. This single-center, three-arm randomized clinical trial evaluates whether (1) Home+Booster VR (an age-appropriate 360° VR module at home \~24-48 hours before MRI plus a brief on-site refresher immediately before positioning), (2) Pre-Scan VR only (same module viewed on site immediately before positioning), or (3) Usual Care without VR improves MRI image quality and tolerance in children undergoing their first-ever MRI. Eligible participants are children scheduled for clinically indicated, non-emergent MRI with no prior MRI experience. Major exclusions comprise MRI contraindications; contraindications to VR use (e.g., uncontrolled epilepsy or severe motion sickness); uncorrected severe visual/hearing impairment precluding VR viewing; and inability to provide assent/consent. After consent/assent, participants are randomized 1:1:1 to one of three arms. Anticipated enrollment is \~150 total (\~50 per arm; up to 60 per arm if feasible). All arms receive routine safety procedures and child-oriented coaching per institutional practice. The VR module (\~8-10 minutes) provides a 360° walkthrough of the MRI process (sounds, positioning, keeping still) with child-focused narration. Adherence (timestamps/duration) is recorded where applicable. The primary outcome is motion artifact rated on a predefined ordinal scale by a board-certified radiologist masked to allocation; the proportion achieving diagnostic quality without repeat/sedation is also reported. Key secondary outcomes include sedation requirement, number of repeated sequences, total scan room time, scan completion without interruption, and change in child anxiety (mYPAS-SF). Additional prespecified measures include comfort/calmness Likert scales, Wong-Baker FACES pain, CEMS during scan, parent state anxiety, satisfaction VAS, physiologic vitals (heart rate, blood pressure, SpO₂) at defined peri-scan time points, observed crying and movement durations, and total scan duration. The trial uses parallel assignment with allocation concealment and masked outcome assessment. Analyses follow intention-to-treat with prespecified subgroup exploration by age bands (5-7 vs 8-10). Recruitment is planned for October 6, 2025; primary completion is expected within approximately three months.

Gastrointestinal, pulmonary, nephrological, cardiac, neurologic and psychological effects in critically ill patients followed in the intensive care unit have been shown in the literature. However, the effects on ovarian reserve in these patients have not been sufficiently investigated and studies investigating this issue are limited in the literature. The synthesis, release frequency and amplitude of reproductive hormones change under stress. In addition, changes in ovarian homeostasis affect ovarian reserve. The aim of this study was to evaluate ovarian reserve in critically ill patients followed up in the intensive care unit.

In the management of pain after Caesarean section (C/S), opioid or nonsteroidal anti-inflammatory parenteral drugs are applied. These drugs are insufficient in some cases and may cause pain attacks during the day. Higher doses and repeated drug applications or combined drug administration may cause drug side effects and interactions. Alternative applications to provide analgesia include subcutaneous and intracutaneous local anesthetic application to the wound site. Although the effectiveness of these applications has been tested in individuals with different clinical characteristics and has been shown to be largely more successful, they have not been sufficiently introduced into routine practice. There is a need to review the pain methods suggested in the literature and develop new solutions that can be applied more optimally, improve the patient's pain management in the postoperative period, and increase their quality of life and satisfaction. It aims to evaluate the success of subcutaneous and intracutaneous local anesthesia applications compared to traditional applications, and to find the most optimal management.

The main purpose of this research is to determine the causes of spinal anesthesia failures during cesarean section due to social, emotional and attitude factors towards surgery and to use this information to improve anesthesia practice.

The study aims primarily to investigate physicians' awareness of their health status, empathy towards patients, and management processes through a questionnaire targeting physicians who diagnose and manage patients' pain.

The aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.

The goal of this observational study is to reveal the relation between carotid flow changes and post-spinal hypotension in pregnant women between the ages of 20-40. The main question it aims to answer is: Do the carotid flow blood flow measurements and corrected flow time change before and after spinal anaesthesia related to postspinal hypotension? Participants are already receiving spinal anaesthesia to receive a caesarean section. As part of their regular anaesthesia management protocol, they will answer questions about anaesthesia management. The participants will only examined by ultrasound twice.

This clinical trial aims to compare the effects of lidocaine, dexmedetomidine, esmolol, and magnesium on optic nerve sheath diameter and hemodynamic response to laryngoscopy. The participants will be patients determined to need intubation and general anesthesia for any elective surgery. Each participant will receive either lidocaine, dexmedetomidine, esmolol, magnesium, or none before anesthesia induction, according to randomization. The investigator will measure the optic nerve sheath diameter by ultrasonography before and after intubation. Researchers will compare the difference between optic nerve sheath diameter, systolic blood pressure, and heart rate before and after laryngoscopy and search for the most stable group. The trial aims to determine a general anesthesia induction protocol for patients sensitive to intracranial pressure changes reflected as optic nerve sheath diameter for easy monitoring.

Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). More research is necessary to define elective surgeries with a possible risk of aspiration. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by measuring and evaluating gastric volume and content with USG in the preoperative operating room.