Effects of dexmedetomidine versus midazolam nasal spray on the eve of surgery on postoperative delirium in elderly patients undergoing knee/hip arthroplasty: A randomized controlled clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500095755

Enrollment

Unknown

Registered

2025-01-13

Start date

2025-01-15

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

knee/hip arthroplasty, postoperative delirium

Interventions

dexmedetomidine group:Before the patient fell asleep, dexmedetomidine will be sprayed into the nasal cavity, 1 spray on each nostril stayed for 30s, and then 1 spray on each nostril for a total of 4 s

midazolam group:Before the patient fell asleep, midazolam will be sprayed into the nasal cavity, 1 spray on each nostril stayed for 30s, and then 1 spray on each nostril for a total of 4 sprays , and

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >= 60 years; 2. ASA grade I-III; 3. Planned to undergo unilateral knee or hip arthroplasty under general anesthesia; 4.Consent to participate in this study and to be followed throughout the postoperative period.

Exclusion criteria

Exclusion criteria: 1.Patients who refused to sign the consent form; 2.Mini-Mental State Examination (MMSE) score <15; 3.Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 4.Inability to communicate in the preoperative period (coma, profound dementia, or language barrier); 5.Known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second degree or greater atrioventricular block without pacemaker; 6.Allergic rhinitis and abnormal nasal structure; 7.Serious hepatic dysfunction (Child-Pugh class C); 8.Serious renal dysfunction (undergoing dialysis before surgery); 9.Allegic to dexmedetomidine and midazolam.

Design outcomes

Primary

Measure	Time frame
Incidence of delirium within 3 days after surgery;	—

Secondary

Measure	Time frame
Duration of delirium;Preoperative sleep quality;Pain score ;Anxiety score;Inflammatory markers;Length of hospital stay;Incidence of nausea and vomiting;Analgesic consumption postoperatively;Incidence of rescue analgesia postoperatively;Time to first ambulation postoperatively;Quality of postoperative recovery;Incidence of delirium within 7 days after surgery;The incidence of hypoxemia;Incidence of respiratory depression;The incidence of hypotension;The incidence of nasal mucous membrane damage;Incidence of arrhythmia;Incidence of hypertension;Severity of delirium;	—

Measure

Time frame

Duration of delirium;Preoperative sleep quality;Pain score ;Anxiety score;Inflammatory markers;Length of hospital stay;Incidence of nausea and vomiting;Analgesic consumption postoperatively;Incidence of rescue analgesia postoperatively;Time to first ambulation postoperatively;Quality of postoperative recovery;Incidence of delirium within 7 days after surgery;The incidence of hypoxemia;Incidence of respiratory depression;The incidence of hypotension;The incidence of nasal mucous membrane damage;Incidence of arrhythmia;Incidence of hypertension;Severity of delirium;

—

Countries

China

Contacts

Public ContactSu Liu

The Affiliated Hospital of Xuzhou Medical University

liusu_xzmu@163.com+86 181 1830 9692

Outcome results

None listed

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