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Safety and feasibility study of esketamine deopioid anesthesia in patients with total knee arthroplasty

Safety and feasibility study of esketamine deopioid anesthesia in patients with total knee arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091328
Enrollment
Unknown
Registered
2024-10-25
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

knee osteoarthritis

Interventions

opioid-free anesthesia :Induction of anesthesia: midazolam 0.05mg/kg, esketamine 0.3-0.4mg/kg, propofol 1-2mg/kg, cisatracurium 0.15-0.2mg/kg Anesthesia maintenance: sevoflurane 1-3%, esketamine 0.125
Opioid anesthesia:Induction of anesthesia: midazolam 0.05mg/kg, Sufentanil 0.3-0.4ug/kg, propofol 1-2mg/kg, cisatracurium 0.15-0.2mg/kg Anesthesia maintenance: sevoflurane 1-3%, remifentanil 0.1-0.2µg

Sponsors

Panzhihua Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 19-80 years old; 2. body mass index (BMI) 18-30kg/m2; 3. American Society of Anesthesiologists (ASA) grades I - III; 4. Selective TKA under general anesthesia; 5. Able to understand and willing to use VAS score to report pain.

Exclusion criteria

Exclusion criteria: 1. The patient refuses; 2. Allergic to drugs used during anesthesia; 3. Long-term use of opioids, sedatives, antidepressants, monoamine oxidase inhibitors and other drugs; 4. Infection of the whole body or puncture site; 5. Preoperative severe complications (coagulation dysfunction, severe hypertension, heart failure, severe arrhythmia, severe lung disease, severe liver and kidney insufficiency, digestive ulcer, mental or nervous system disease, cognitive dysfunction); 6. Refusing postoperative analgesia; 7. Chronic pain in the past; 8. Obstructive sleep apnea syndrome; 9. Language communication barriers; 10. Follow-up failure or withdrawal.

Design outcomes

Primary

MeasureTime frame
Total Sufentanil consumption 48 hours after surgery (ug);Total Sufentanil consumption 48 hours after surgery (ug);PONV;Incidence of chronic wound pain at 1 month, 3 months and 6 months after surgery;

Secondary

MeasureTime frame
Heart rate before anesthesia induction (T0), intubation time (T1), incision time (T2), after surgery time (T3), extubation time (T4);The mean arterial pressure changes before anesthesia induction (T0), at intubation time (T1), at incision time (T2), at the end of surgery (T3), at extubation time (T4) and at extubation time (T4);Rest and Exercise Visual Analog Pain Scale Score (VAS) rating;Ramsay Sedation Scale (RSS); Patient Satisfaction Score;First time of getting out of bed activity; Postoperative complications (postoperative delirium, hypoxemia, hypotension, bradycardia, respiratory depression, itching, etc.).; Length of hospital stay (defined as the time from the end of surgery to discharge);

Countries

China

Contacts

Public ContactMu sihai

Panzhihua Central Hospital

379649925@qq.com+86 180 9630 7250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026