- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445659
qCON/qNOX-Guided Anesthesia in Patients Undergoing Thyroidectomy Surgery
The Effect of qCON/qNOX-Guided Anesthesia Using the Conox Monitor on Clinical Outcomes in Patients Undergoing Thyroidectomy Surgery
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Çiğdem Ünal Kantekin, MD
- Phone Number: +905054433056
- Email: drcgdm@gmail.com
Study Locations
-
-
Kayseri
-
Kayseri, Kayseri, Turkey (Türkiye), 38080
- Recruiting
- Kayseri City Hospital
-
Contact:
- Çiğdem Ünal Kantekin
- Phone Number: 5054433056
- Email: drcgdm@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-70 years
- Thyroidectomy cases with ASA physical status I-II
- Patients who have provided written informed consent
Exclusion Criteria:
- Skin lesions preventing EEG electrode placement
- Neurological disorders (e.g., epilepsy)
- Anticipated difficult airway
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conox
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. |
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.
|
|
Active Comparator: control
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between qCON/qNOX values and hemodynamic parameters
Time Frame: Intraoperative period
|
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.
|
Intraoperative period
|
|
Postoperative pain scores
Time Frame: Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes)
|
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).
|
Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: çiğdem ünal kantekin, MD, Kayseri City Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KSH-SBU-CUK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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