Cesarean Section (MeSH: D002585)NCT07887919
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
An observational study of Cesarean Section (MeSH: D002585) and Anesthesia, run by Kudret Dogru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section (MeSH: D002585), Anesthesia, Intraoperative Awareness
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 31 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: American Society of Anesthesiologists II pregnant women aged between 18-45 years
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia Applied for Cesarean Section Operations
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.
Read the detailed description
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.
- Keywords
- Cesarean Section, General Anesthesia, Electroencephalography, Nociceptive Pain
- Medical subject headings
- Intraoperative Awareness, Agnosia, Nociceptive Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From the anesthesia induction to emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section (MeSH: D002585)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kudret Dogru
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Kudret Dogru, TC Erciyes University
- Investigators
- Meryem Cemile Acar, Asistant Dr., Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887919
- Sponsor's protocol ID
- 2026/01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia Applied for Cesarean Section Operations
- ClinicalTrials.gov ID
- NCT07887919
- Acronym / sponsor ID
- 2026/01
- Keywords
- Cesarean Section, General Anesthesia, Electroencephalography, Nociceptive Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kudret DogruUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- American Society of Anesthesiologists II pregnant women aged between 18-45 years
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Consciousness Depth (qCON) changes during induction
Time frame: From the anesthesia induction to emergence from anesthesia
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).
Evaluation of Analgesia Depth (qNOX) changes during induction
Time frame: From the anesthesia induction to emergence from anesthesia
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).
Evaluation of electromyography (EMG) changes during induction
Time frame: From the anesthesia induction to emergence from anesthesia
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).
Evaluation of standard hemodynamics (HR, MAP, SpO2, EtCO2) changes during induction
Time frame: From the anesthesia induction to emergence from anesthesia
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meryem Cemile Acar, Asistant Dr. principal investigator
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section (MeSH: D002585) and Anesthesia, run by Kudret Dogru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kudret Doğru, Prof. Dr. (05334735112, kdogru@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Consciousness Depth (qCON) changes during induction (time frame: From the anesthesia induction to emergence from anesthesia). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.