An observational study in Cesarean Section (MeSH: D002585), Anesthesia and Intraoperative Awareness, sponsored by Kudret Dogru. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Kudret Dogru · Observational
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.
Objective: This prospective, single-center, observational clinical study aims to evaluate changes in qCON (hypnotic depth), qNOX (nociception/analgesia depth), and EMG 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 on 140 patients planned for elective cesarean section under general anesthesia (alpha = 0.05, 90% power, effect size = 0.50). Standard hemodynamics (HR, MAP, SpO_2, and EtCO_2) along with qCON, qNOX, and EMG will be recorded at six predefined timepoints (T_0: pre-induction, T_1: 1 min post-induction, T_2: 3 min post-intubation, T_3: 1 min post-skin incision, T_4: 1 min post-delivery, and T_5: 5 min into emergence). Exclusion criteria include dermatological lesions affecting EEG sensors, neurological disorders, BMI > 40 kg/m², preeclampsia/eclampsia, preoperative sedative use, and difficult intubation history.
Outcomes: The primary outcome is the evaluation of changes and agreement among qNOX, qCON, and BIS during induction. Secondary outcomes include qNOX/qCON variations during intubation, the assessment of the hypnotic-antinociceptive balance, and their relationship with hemodynamic parameters.
54 studies on the registry are indexed under Intraoperative Awareness; 8 are open to participants now.
This study's planned enrollment of 140 is above the median of 115 across 27 observational studies indexed under Intraoperative Awareness.
Browse Intraoperative Awareness studies →This is the only study on the registry with Kudret Dogru as lead sponsor.
Counted across the registry records on this site, refreshed daily.
American Society of Anesthesiologists II pregnant women aged between 18-45 years
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Evaluation of Consciousness Depth (qCON) changes during induction
qCON values recorded at predefined timepoints (T\_0: Pre-induction, T\_1: 1 min post-induction, T\_2: 3 min post-intubation, T\_3: 1 min post-skin incision, T\_4: 1 min post delivery, T\_5: 5 min into emergence).
Time frame: From the anesthesia induction to emergence from anesthesia
Evaluation of Analgesia Depth (qNOX) changes during induction
qNOX values recorded at predefined timepoints (T\_0: Pre-induction, T\_1: 1 min post-induction, T\_2: 3 min post-intubation, T\_3: 1 min post-skin incision, T\_4: 1 min post delivery, T\_5: 5 min into emergence).
Time frame: From the anesthesia induction to emergence from anesthesia
Evaluation of electromyography (EMG) changes during induction
EMG values recorded at predefined timepoints (T\_0: Pre-induction, T\_1: 1 min post-induction, T\_2: 3 min post-intubation, T\_3: 1 min post-skin incision, T\_4: 1 min post delivery, T\_5: 5 min into emergence).
Time frame: From the anesthesia induction to emergence from anesthesia
Evaluation of standard hemodynamics (HR, MAP, SpO2, EtCO2) changes during induction
Standard hemodynamics parameters (HR, MAP, SpO\_2, EtCO\_2) recorded at predefined timepoints (T\_0: pre-induction, T\_1: 1 min post-induction, T\_2: 3 min post-intubation, T\_3: 1 min post-skin incision, T\_4: 1 min post-delivery, T\_5: 5 min into emergence).
Time frame: From the anesthesia induction to emergence from anesthesia
No study locations are listed for this record.
Plan to share: No
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.