NCT07445659

Brief 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 values and conventional hemodynamic parameters.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

February 25, 2026

Last Update Submit

April 16, 2026

Conditions

Thyroid SurgeriesIntraoperative Analgesic UseAnesthesia Depth Monitoring

Keywords

thyroid surgeryintraoperative opioid consumptionanesthesia depth monitoringqCONqNOX

Outcome Measures

Primary Outcomes (1)

  • 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.

    Intraoperative period

Secondary Outcomes (2)

  • Correlation between qCON/qNOX values and hemodynamic parameters

    Intraoperative period

  • Postoperative pain scores

    Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes)

Study Arms (2)

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.

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.

Other: standard anesthesia management

Interventions

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.

Conox
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.

control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-70 years
  • Thyroidectomy cases with ASA physical status I-II
  • Patients who have provided written informed consent

You may not qualify if:

  • Skin lesions preventing EEG electrode placement
  • Neurological disorders (e.g., epilepsy)
  • Anticipated difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, 38080, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35699795BACKGROUND

Study Officials

  • çiğdem ünal kantekin, MD

    Kayseri City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Çiğdem Ünal Kantekin, MD

CONTACT

+905054433056drcgdm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)