Efficacy of perioperative ozone rectal insufflation therapy on postoperative delirium in elderly patients undergoing knee and hip arthroplasty

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500108407

Enrollment

Unknown

Registered

2025-08-29

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

Postoperative delirium in elderly patients undergoing knee and hip arthroplasty

Interventions

Group O3:ozone rectal insufflation

Group C:None

Eligibility

Sex/Gender

All

Age

65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Over 65 years old; 2.ASA classification is Grade I to III; 3.Scheduled for THA or TKA; 4.Agree to participate in this study and accept the full postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1.Mini-Mental State Examination (MMSE) score < 15; 2.Contraindications for ozone rectal insufflation; 3.Neuropsychiatric disorders and history of previous neurological or psychiatric disorders; 4.Drug or alcohol abuse; 5.Visual or hearing impairments,; 6.History of severe cardiovascular disease or severe liver or renal dysfunction;

Design outcomes

Primary

Measure	Time frame
the incidence of POD;	—

Secondary

Measure	Time frame
delirium subtypes, delirium severity and delirium duration;Anxiety and depression conditions;Numeric Rating Scale (NRS) both at rest and motion;The usage of postoperative analgesic drugs;30-day all-cause mortality;length of hospitalization;the incidence of complications;Postoperative recovery quality;	—

Countries

China

Contacts

Public ContactFang Ming

Affiliated Hospital of Jiangnan University

forlavi@vip.163.com+86 510 8868 2009

Outcome results

None listed

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