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A randomized controlled trial of micro-dose lidocaine intravenous infusion based on multimodal analgesia for the prevention of delirium after hip fracture

A randomized controlled trial of micro-dose lidocaine intravenous infusion based on multimodal analgesia for the prevention of delirium after hip fracture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104689
Enrollment
Unknown
Registered
2025-06-20
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Hip Fracture Surgery

Interventions

Intervention group:Continuous intravenous infusions of combined lidocaine (0.1 mg/kg/hour), dexmedetomidine (3 ug/kg), and sufentanil (1 ug/kg) were started before the skin incision and continued for
Control group:Continuous intravenous infusion of dexmedetomidine (3 ug/kg) and sufentanil (1 ug/kg) was started before skin incision and continued for 48 hours.

Sponsors

The People's Hospital of Jizhou District, Tianjin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Clinical or imaging diagnosis of intracapsular or extracapsular hip fracture 2. Planned surgical treatment by hemi-hip arthroplasty, total hip arthroplasty, or appropriate fixation surgery 3. Age>=50 years

Exclusion criteria

Exclusion criteria: 1. ASA physical condition classification >=IV 2. Patients weighing outside the range of 40-100kg 3. Patients who have delirium before surgery 4. Contraindications to lidocaine and dexmedetomidine 5. Allergy to the study drug 6. Plan postoperative mechanical ventilation 7. Patients with known or suspected patients are at high risk of malignant hyperthermia 8. Inability to communicate or understand study instructions 9. Patients with a history of drug abuse (such as ketamine, cocaine, heroin, amphetamines, phencyclidine, lysergic acid, mescalin, psilocybin) 10. Patients with neurological disorders or taking antipsychotic drugs (such as chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, paliperidone, amisulpride, sertralindole) 11. Severe heart disease (such as severe aortic stenosis, severe heart block, A-S syndrome, pre-excitation syndrome) 12. Patients with renal or hepatic impairment 13. Patients who are unable to correct electrolyte imbalances 14. Refusal of the patient or authorized agent to provide informed consent

Design outcomes

Primary

MeasureTime frame
Postoperative delirium;

Secondary

MeasureTime frame
Rescue opioids use;Acute postoperative pain;Patient satisfaction;Quality of recovery;Hospital length of stay;Chronic pain;

Countries

China

Contacts

Public ContactTengjiao Zhang

The People's Hospital of Jizhou District, Tianjin

15127323212@163.com+86 185 3358 8623

Outcome results

None listed

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