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Effects of qCON and qNOX-guided general anesthesia management on patient opioid use and prognosis: a randomized, single-blind, standard controlled clinical study

Effects of qCON and qNOX-guided general anesthesia management on patient opioid use and prognosis: a randomized, single-blind, standard controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059877
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anesthesia

Interventions

Control group:Standard monitoring guidance
Experimental group:qCON and qNOX monitoring guidance

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged > 18 years; 2. ASA I~III level; 3. Abdominal, urological, thoracic or orthopedic surgery performed under general anesthesia via laparoscopy or cesarean section; 4. Expected anesthesia time more than 60 min and postoperative transfer to PACU; 5. Consciously comply with the procedure of this experiment and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Non-elective surgery; 2. Intraspinal or any form of regional anesthesia is planned; 3. Preoperative acute or chronic pain, peripheral or central nervous system disorders, chronic opioid or non-opioid pain medications; 4. History of clearly diagnosed psychiatric disorders or other neurological or psychiatric conditions affecting the judgment of severe cognitive impairment, history of psychoactive drug use; 5. History of severe underlying disease (untreated or persistent peripheral or central cardiovascular disease, severe liver or kidney disease, severe pulmonary disease).

Design outcomes

Primary

MeasureTime frame
Intraoperative opioid dosage;Perioperative cognitive function changes;

Secondary

MeasureTime frame
Total amount of propofol;Inflammation and stress level monitoring;Dosage of self-controlled analgesics;Hemodynamic fluctuations;Use of vasoactive drugs;Pain score;Postoperative delirium;Correlation between BIS values and qCON values;Time correlation between qCON values and qNOX values;Predictive ability of qCON and qNOX for recovery of consciousness;Speed of recovery of qCON versus qNOX after discontinuation of general anesthetics.;Monitoring ability and predictive power of qCON and qNOX for muscle relaxation and body movement;Correlation of qCON and qNOX with nociceptive stimuli;Time correlation of qNOX with opioids;Effect of beta-blocker use on qCON and qNOX;Effect of body temperature on qCON and qNOX;Factors influencing qCON and qNOX;Induction time of anesthesia;General anesthesia awakening time;Change of anxiety level;Change in sleep rhythm;Incidence of hypotension requiring treatment;Incidence of hypertension requiring treatment;Incidence of bradycardia requiring treatment;Incidence of tachycardia requiring treatment;Incidence of respiratory depression in PACU;Incidence of chills after awakening;Levels of frailty in old age correlate with altered cognitive function;Subject satisfaction;Researcher satisfaction;

Countries

China

Contacts

Public ContactLi Yize

Tianjin Medical University General Hospital

liyizelisa@126.com+86 13512224465

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026