Effects of opioid-free and opioid-based anesthesia on immune function in elderly patients after unilateral knee arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069836

Enrollment

Unknown

Registered

2023-03-27

Start date

2024-07-07

Completion date

Unknown

Last updated

2026-03-23

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

Conditions

None listed

Interventions

OFA group:Anesthesia induction: Propofol 1.5-2 mg/kg, Lidocaine 1-1.5 mg/kg, Esketamine 0.2-0.5 mg/kg, and Cisatracurium 0.15 mg/kg

Anesthesia maintenance: Esketamine 0.1-0.5 mg/(kg·h), Dexmedetomidine 0.4-1.4 µg/(kg·h), Lidocaine 1 mg/(kg·h), and Sevoflurane.

OBA group :Anesthesia induction: Propofol 1.5-2 mg/kg, Lidocaine 1-1.5 mg/kg, Sufentanil 0.1-0.5 µg/kg, and Cisatracurium 0.15 mg/kg

Anesthesia maintenance: Remifentanil 8-10 µg/(kg·h), Dexmedetomidine 0.4-1.4 µg/(kg·h), Lidocaine 1 mg/(kg·h), and Sevoflurane.

Eligibility

Sex/Gender

All

Age

60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Elderly patients admitted to the center, age range: 60 to 80 years old; 2. Accepting unilateral knee replacement surgery; 3. Sign an informed consent form; 4. BMI: 20-30 kg/m2; 5. ASA I-III level.

Exclusion criteria

Exclusion criteria: 1. Allergies to drugs or their excipients used for anesthesia; 2. Atrial ventricular block, intraventricular or sinoatrial block; 3. Adam Stokes syndrome; 4. Long term acceptance ß- Blockers and HR<50 times/minute; 5. Severe cardiovascular diseases (such as angina pectoris and myocardial infarction); 6. High intraocular pressure; 7. Hyperthyroidism; 8. Contraindications to nerve block; 9. Long term history of analgesic drug use; 10. Suffering from mental illness or inability to communicate normally.

Design outcomes

Primary

Measure	Time frame
The proportion of NK cells in total lymphocytes;	—

Secondary

Measure	Time frame
visual analogue scale, VAS;Active knee flexion maximum angle and walking distance;The proportion of CD3+ cells in total lymphocytes;The proportion of CD4+ cells in total lymphocytes;The proportion of CD8+ cells in total lymphocytes;Number of effective compressions in PCIA;Opioid consumption;Mean arterial pressure;Heart rate;Bispectral Index, BIS;Dosage of vasoactive drugs;Local anesthetic poisoning situation;Time of endotracheal tube extubation;Incidence rate of postoperative nausea and vomiting;Pittsburgh sleep quality index,PSQI;Rescue analgesia;Length of hospital stay;The proportion of B lymphocytes in total lymphocytes;	—

Measure

Time frame

visual analogue scale, VAS;Active knee flexion maximum angle and walking distance;The proportion of CD3+ cells in total lymphocytes;The proportion of CD4+ cells in total lymphocytes;The proportion of CD8+ cells in total lymphocytes;Number of effective compressions in PCIA;Opioid consumption;Mean arterial pressure;Heart rate;Bispectral Index, BIS;Dosage of vasoactive drugs;Local anesthetic poisoning situation;Time of endotracheal tube extubation;Incidence rate of postoperative nausea and vomiting;Pittsburgh sleep quality index,PSQI;Rescue analgesia;Length of hospital stay;The proportion of B lymphocytes in total lymphocytes;

—

Countries

China

Contacts

Public ContactChaobo Ni

The Affiliated Hospital of Jiaxing University, Jiaxing, China

jxnichaobo@zjxu.edu.cn+86 137 5807 0124

Outcome results