Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:11 AM
Study NCT ID:
NCT07445659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
qCON/qNOX-Guided Anesthesia in Patients Undergoing Thyroidectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total intraoperative opioid consumption', 'timeFrame': 'Intraoperative period', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between qCON/qNOX values and hemodynamic parameters', 'timeFrame': 'Intraoperative period', 'description': '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.'}, {'measure': 'Postoperative pain scores', 'timeFrame': 'Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes)', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid surgery', 'intraoperative opioid consumption', 'anesthesia depth monitoring', 'qCON', 'qNOX'], 'conditions': ['Thyroid Surgeries', 'Intraoperative Analgesic Use', 'Anesthesia Depth Monitoring']}, 'referencesModule': {'references': [{'pmid': '35699795', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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 .\n\nAlthough 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.\n\nIn 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 .\n\nThe 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.\n\nBy 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.\n\nThis study aims to investigate whether Conox monitoring provides clinical advantages compared with routine physiological parameter monitoring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-70 years\n* Thyroidectomy cases with ASA physical status I-II\n* Patients who have provided written informed consent\n\nExclusion Criteria:\n\n* Skin lesions preventing EEG electrode placement\n* Neurological disorders (e.g., epilepsy)\n* Anticipated difficult airway'}, 'identificationModule': {'nctId': 'NCT07445659', 'briefTitle': 'qCON/qNOX-Guided Anesthesia in Patients Undergoing Thyroidectomy Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri City Hospital'}, 'officialTitle': 'The Effect of qCON/qNOX-Guided Anesthesia Using the Conox Monitor on Clinical Outcomes in Patients Undergoing Thyroidectomy Surgery', 'orgStudyIdInfo': {'id': 'KSH-SBU-CUK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conox', 'description': '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.\n\nIn the Conox group, anesthetic and analgesic titration will be performed targeting qCON values of 40-60 and qNOX values of 30-60.', 'interventionNames': ['Device: Connox EEG Monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': '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.\n\nTotal intraoperative opioid consumption, recovery time, extubation time, agitation scores, and pain scores will be recorded.', 'interventionNames': ['Other: standard anesthesia management']}], 'interventions': [{'name': 'Connox EEG Monitoring', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Conox']}, {'name': 'standard anesthesia management', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38080', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Çiğdem Ünal Kantekin', 'role': 'CONTACT', 'email': 'drcgdm@hotmail.com', 'phone': '5054433056'}], 'facility': 'Kayseri City Hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Çiğdem Ünal Kantekin, MD', 'role': 'CONTACT', 'email': 'drcgdm@gmail.com', 'phone': '+905054433056'}], 'overallOfficials': [{'name': 'çiğdem ünal kantekin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Çiğdem Ünal Kantekin', 'investigatorAffiliation': 'Kayseri City Hospital'}}}}