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The Opioid-free anesthesia-analgesia modality could improve QoR15 in the patients undergoing total replacement

The Opioid-free anesthesia-analgesia modality could improve QoR15 in the patients undergoing total replacement

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085740
Enrollment
Unknown
Registered
2024-06-17
Start date
2024-06-17
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

total knee replacement

Interventions

opioid group:Combination application of opioids for anesthesia and postoperative analgesia protocols
Opioid-free group:Opioid-free general anesthesia and postoperative analgesic protocols

Sponsors

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18 years old <= age <= 80 years old; 2) ASA grade I-III; 3) Type of surgery: adult patients undergoing elective unilateral knee replacement under general anesthesia; 4) BMI of 18.5~30 kg/m^2 [BMI=Weight (Kg) /Height (m) ^2]. 5) Ethical, voluntary and informed consent.

Exclusion criteria

Exclusion criteria: 1) History of undergoing general anesthesia for surgery within one month prior to surgery; 2) Coexisting severe systemic diseases of the cardiovascular, pulmonary, and cerebral systems, such as hypertension, coronary heart disease, COPD, asthma, respiratory failure, pulmonary hypertension, severe cardiac arrhythmias (atrial fibrillation, second-degree or higher atrioventricular block, sick sinus syndrome, etc.), severe valvular heart disease, heart failure, renal failure, stroke and myocardial infarction within the past 6 months, Alzheimer's disease, Parkinson's disease, mental illness, OSAS, myasthenia gravis, etc.; 3) History of chronic pain in other parts of the body; 4) Patients with impaired liver or kidney function; 5) Patients with a history of allergy to the drugs used in this study; 6) Patients with a history of opioid abuse and use of opioid drugs within the past two weeks; 7) Abnormal coagulation function; 8) Patients with METs<4; 9) Patients who refuse or are unable to participate in this study; 10) Patients who participated in another study within the past 30 days.

Design outcomes

Primary

MeasureTime frame
Postoperative Quality of Recovery Score (QoR-15);

Secondary

MeasureTime frame
Postoperative Quality of Recovery Score (QoR-15);hemodynamic parameter;IoC Awareness Injury Index;

Countries

China

Contacts

Public ContactJunde Han

Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

hanjunde416@163.com+86 189 3017 0287

Outcome results

None listed

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