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NCT07887919
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Conditions: Cesarean Section (MeSH: D002585), Anesthesia, Intraoperative Awareness, Analgesia
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Enrollment: 140
Sponsor: Kudret Dogru
Summary
Objective: This prospective, single-center, observational clinical study aims to evaluate changes in qCON (hypnotic depth), qNOX (nociception/analgesia depth), EMG, and other parameters in patients undergoing elective cesarean section under general anesthesia, with a focus on the induction and maintenance phases.
Background: Primary goals in cesarean anesthesia include maintaining adequate anesthetic depth to prevent awareness and intraoperative recall, preserving uterine tone, and avoiding neonatal respiratory depression. While high inhalation agent concentrations increase uterine relaxation and bleeding risks, opioids administered during the incision-to-delivery interval can cause neonatal respiratory depression. Alternative anesthetic combinations (e.g., ketamine-propofol) are used in practice, but their effects on EEG-derived indices (qCON and qNOX) and potential paradoxical shifts remain poorly defined.
Methods: The study will be conducted at Erciyes University Faculty of Medicine Hospital in 140 patients planned for elective cesarean section under general anesthesia (alpha = 0.05, 90% power, effect size = 0.50), including a history of eclampsia, preoperative sedative use, and difficult intubation.
Eligibility Criteria
Inclusion Criteria:
Pregnant women scheduled for elective cesarean section
Aged 18-45 years
American Society of Anesthesiologists II-III
Patients with an indication for general anesthesia
Patients who provided informed consent to participate in the study
Exclusion Criteria:
Dermatological lesions that may interfere with EEG monitoring
Known allergy or hypersensitivity to ketamine, remifentanil, or propofol
History or presence of neurological disease (e.g., epilepsy)
Body Mass Index (BMI) \> 40 kg/m²
Preeclampsia or eclampsia
Preoperative sedative or psychotropic medication use
Predicted or known difficult tracheal intubation
Source: ClinicalTrials.gov (NCT07887919). StuddyBuddy aggregates publicly available trial information.