Thyroid SurgeriesNCT07445659
qCON/qNOX-Guided Anesthesia in Patients Undergoing Thyroidectomy Surgery
A study testing Connox EEG Monitoring and standard anesthesia management in people with Thyroid Surgeries and Intraoperative Analgesic Use, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of using the non-invasive Conox monitor on intraoperative opioid consumption. Additionally, the study aims to assess the impact of Conox monitoring on recovery time, postoperative agitation rate, and pain scores, and to investigate the correlation between qCON and qNOX… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Surgeries, Intraoperative Analgesic Use, Anesthesia Depth Monitoring
- What is being tested?
- Connox EEG Monitoring and standard anesthesia management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years
- Thyroidectomy cases with ASA physical status I-II
- Patients who have provided written informed consent
Who cannot join
- Skin lesions preventing EEG electrode placement
- Neurological disorders (e.g., epilepsy)
- Anticipated difficult airway
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri City Hospital
Kayseri, Kayseri, 38080
Çiğdem Ünal Kantekin, 5054433056, drcgdm@hotmail.com
About this study
Official title: The Effect of qCON/qNOX-Guided Anesthesia Using the Conox Monitor on Clinical Outcomes in Patients Undergoing Thyroidectomy Surgery
The aim of this study is to evaluate the effect of using the non-invasive Conox monitor on intraoperative opioid consumption. Additionally, the study aims to assess the impact of Conox monitoring on recovery time, postoperative agitation rate, and pain scores, and to investigate the correlation between qCON and qNOX values and conventional hemodynamic parameters.
Read the detailed description
In recent years, both nationally and internationally, strategies aimed at minimizing perioperative opioid use and protocols designed to enhance postoperative recovery have gained increasing importance in anesthesia practice. The primary objectives of these developments are to improve patient care, minimize undesirable events, promote earlier discharge, and prevent long-term adverse outcomes .
Although opioids play an essential role in multimodal perioperative analgesia due to their proven efficacy, safety, and titratability, it is important to use the lowest effective opioid dose possible.
In thyroid surgery, neuromuscular blocking agents are not used after induction. Maintenance of anesthesia is achieved with inhalational anesthetic agents and opioids. Therefore, adequate titration of anesthetic depth directly affects postoperative comfort, drug consumption, and overall recovery .
The Conox monitor is a non-invasive, EEG-based monitoring device that simultaneously provides hypnosis (qCON) and analgesia/nociception (qNOX) indices. The current anesthesia depth monitoring devices used in our anesthesia unit allow monitoring of anesthetic depth only. However, nociception is one of the critical components of anesthesia. Nociception is defined as the patient's ability to respond to painful stimuli in relation to the effectiveness of administered analgesic agents. Proper management of painful stimuli during surgery enhances patient safety and allows optimal drug dosing.
By reducing unnecessary drug administration, postoperative complications may decrease and recovery can be positively influenced. The Conox monitoring system, based on EEG signals, offers the opportunity to monitor both anesthetic depth and nociception simultaneously . Combined monitoring of anesthetic depth and nociception provides anesthesiologists with a safer, more sensitive, and comprehensive monitoring approach, thereby improving the quality of patient care.
This study aims to investigate whether Conox monitoring provides clinical advantages compared with routine physiological parameter monitoring.
- Being tested
- Connox EEG Monitoring, standard anesthesia management
- Keywords
- thyroid surgery, intraoperative opioid consumption, anesthesia depth monitoring, qCON, qNOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connox EEG MonitoringDevice
Conox EEG monitor will be applied intraoperatively. Anesthetic and opioid titration will be guided by qCON values between 40-60 and qNOX values between 30-60. Opioid administration will be adjusted according to qNOX levels in addition to standard clinical monitoring.
standard anesthesia managementOther
Standard anesthesia management will be performed according to routine clinical practice. Opioid titration will be guided by conventional hemodynamic parameters including heart rate and mean arterial pressure. No EEG-based monitoring will be used for analgesia titration.
| Study group | Role | What they receive |
|---|---|---|
| Conox | Experimental | Induction: Propofol 2-3 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg. Maintenance: Sevoflurane (1.0-1.3 MAC) and remifentanil infusion at 0.1 µg/kg/h.
In the Conox group, anesthetic and analgesic titration will be performed targeting qCON values of 40-60 and qNOX values of 30-60. Receives: Device: Connox EEG Monitoring |
| control | Active comparator | Induction: Propofol 2-3 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg. Maintenance: Sevoflurane (1.0-1.3 MAC) and remifentanil infusion at 0.1 µg/kg/h.In the control group, conventional titration will be guided by heart rate and mean arterial pressure changes.
Total intraoperative opioid consumption, recovery time, extubation time, agitation scores, and pain scores will be recorded. Receives: Other: standard anesthesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative opioid consumption
Total intraoperative opioid consumption will be defined as the cumulative dose of remifentanil (µg/kg) administered from induction of anesthesia until completion of surgery (skin closure). Data will be obtained from anesthesia records and analyzed comparatively between the study groups.
Measured: Intraoperative period
Secondary outcomes (2)
Correlation between qCON/qNOX values and hemodynamic parameters
The correlation between qCON and qNOX indices and hemodynamic parameters (heart rate and mean arterial pressure) will be evaluated during the intraoperative period. Values will be recorded at predefined intervals and analyzed using correlation analysis.
Measured: Intraoperative period
Postoperative pain scores
Postoperative pain intensity will be assessed using the Visual Analog Scale(VAS), A 0 to 10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded every five minutes during the first 30 minutes in the post-anesthesia care unit (PACU).
Measured: Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start10 Apr 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid SurgeriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Çiğdem Ünal Kantekin, Kayseri City Hospital
- Investigators
- çiğdem ünal kantekin, MD, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445659
- Sponsor's protocol ID
- KSH-SBU-CUK-01
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional regulations and ethical considerations. The study will be conducted at a single center, and data sharing was not included in the informed consent process.
Publications
Mun-Price C, Than K, Klein MJ, Ross P, Kim E, Hochstim C, Nagoshi M. The effect of anesthesia without opioid on perioperative opioid demand in children with severe obstructive sleep apnea (OSA) for adenotonsillectomies - single-center retrospective observational study. JA Clin Rep. 2022 Jun 14;8(1):41. doi: 10.1186/s40981-022-00530-7.
PubMed 35699795
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of qCON/qNOX-Guided Anesthesia Using the Conox Monitor on Clinical Outcomes in Patients Undergoing Thyroidectomy Surgery
- ClinicalTrials.gov ID
- NCT07445659
- Acronym / sponsor ID
- KSH-SBU-CUK-01
- Keywords
- thyroid surgery, intraoperative opioid consumption, anesthesia depth monitoring, qCON, qNOX
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Mar 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.
The aim of this study is to evaluate the effect of using the non-invasive Conox monitor on intraoperative opioid consumption. Additionally, the study aims to assess the impact of Conox monitoring on recovery time, postoperative agitation rate, and pain scores, and to investigate the correlation between qCON and qNOX values and conventional hemodynamic parameters.
Detailed description
In recent years, both nationally and internationally, strategies aimed at minimizing perioperative opioid use and protocols designed to enhance postoperative recovery have gained increasing importance in anesthesia practice. The primary objectives of these developments are to improve patient care, minimize undesirable events, promote earlier discharge, and prevent long-term adverse outcomes .
Although opioids play an essential role in multimodal perioperative analgesia due to their proven efficacy, safety, and titratability, it is important to use the lowest effective opioid dose possible.
In thyroid surgery, neuromuscular blocking agents are not used after induction. Maintenance of anesthesia is achieved with inhalational anesthetic agents and opioids. Therefore, adequate titration of anesthetic depth directly affects postoperative comfort, drug consumption, and overall recovery .
The Conox monitor is a non-invasive, EEG-based monitoring device that simultaneously provides hypnosis (qCON) and analgesia/nociception (qNOX) indices. The current anesthesia depth monitoring devices used in our anesthesia unit allow monitoring of anesthetic depth only. However, nociception is one of the critical components of anesthesia. Nociception is defined as the patient's ability to respond to painful stimuli in relation to the effectiveness of administered analgesic agents. Proper management of painful stimuli during surgery enhances patient safety and allows optimal drug dosing.
By reducing unnecessary drug administration, postoperative complications may decrease and recovery can be positively influenced. The Conox monitoring system, based on EEG signals, offers the opportunity to monitor both anesthetic depth and nociception simultaneously . Combined monitoring of anesthetic depth and nociception provides anesthesiologists with a safer, more sensitive, and comprehensive monitoring approach, thereby improving the quality of patient care.
This study aims to investigate whether Conox monitoring provides clinical advantages compared with routine physiological parameter monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conox | Experimental | Device: Connox EEG MonitoringInduction: Propofol 2-3 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg. Maintenance: Sevoflurane (1.0-1.3 MAC) and remifentanil infusion at 0.1 µg/kg/h. In the Conox group, anesthetic and analgesic titration will be performed targeting qCON values of 40-60 and qNOX values of 30-60. |
| control | Active comparator | Other: standard anesthesia managementInduction: Propofol 2-3 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg. Maintenance: Sevoflurane (1.0-1.3 MAC) and remifentanil infusion at 0.1 µg/kg/h.In the control group, conventional titration will be guided by heart rate and mean arterial pressure changes. Total intraoperative opioid consumption, recovery time, extubation time, agitation scores, and pain scores will be recorded. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-70 years
- Thyroidectomy cases with ASA physical status I-II
- Patients who have provided written informed consent
Key exclusion criteria (3 listed)
- Skin lesions preventing EEG electrode placement
- Neurological disorders (e.g., epilepsy)
- Anticipated difficult airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connox EEG MonitoringConox EEG monitor will be applied intraoperatively. Anesthetic and opioid titration will be guided by qCON values between 40-60 and qNOX values between 30-60. Opioid administration will be adjusted according to qNOX levels in addition to standard clinical monitoring. | Device | Conox |
| standard anesthesia managementStandard anesthesia management will be performed according to routine clinical practice. Opioid titration will be guided by conventional hemodynamic parameters including heart rate and mean arterial pressure. No EEG-based monitoring will be used for analgesia titration. | Other | control |
Primary outcome
Total intraoperative opioid consumption
Time frame: Intraoperative period
Total intraoperative opioid consumption will be defined as the cumulative dose of remifentanil (µg/kg) administered from induction of anesthesia until completion of surgery (skin closure). Data will be obtained from anesthesia records and analyzed comparatively between the study groups.
2 secondary outcomes
Correlation between qCON/qNOX values and hemodynamic parameters
Time frame: Intraoperative period
Postoperative pain scores
Time frame: Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes)
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 20 Apr 2026.
- Background: PubMed 35699795Mun-Price C, Than K, Klein MJ, Ross P, Kim E, Hochstim C, Nagoshi M. The effect of anesthesia without opioid on perioperative opioid demand in children with severe obstructive sleep apnea (OSA) for adenotonsillectomies - single-center retrospective observational study. JA Clin Rep. 2022 Jun 14;8(1):41. doi: 10.1186/s40981-022-00530-7.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional regulations and ethical considerations. The study will be conducted at a single center, and data sharing was not included in the informed consent process.
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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.
çiğdem ünal kantekin, MD principal investigator
Kayseri City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connox EEG Monitoring and standard anesthesia management in people with Thyroid Surgeries and Intraoperative Analgesic Use, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Çiğdem Ünal Kantekin, MD (+905054433056, drcgdm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative opioid consumption (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445659, which also lists 1 linked publication.
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 20 Apr 2026.