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Effect of Low-Dose Dexmedetomidine Combined with Goal-Directed Cerebral Oxygen Saturation Monitoring on Postoperative Delirium in Elderly Frail Patients Undergoing Complex Arthroscopic Shoulder Surgery

Effect of Low-Dose Dexmedetomidine Combined with Goal-Directed Cerebral Oxygen Saturation Monitoring on Postoperative Delirium in Elderly Frail Patients Undergoing Complex Arthroscopic Shoulder Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100658
Enrollment
Unknown
Registered
2025-04-13
Start date
2024-02-17
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Postoperative Delirium

Interventions

Normal saline group:Equal volume of saline infusion,continued until 15 minutes before the end of surgery
Dexmedetomidine group:A loading dose of dexmedetomidine 0.4 mg/kg is administered over 10 minutes, followed by a maintenance infusion of 0.2–0.4 µg/kg/h (concentration: 4 mg/mL), continued until 15 mi

Sponsors

Li Huili Hospital Affiliated to Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: There were 96 senile and frail patients with complex shoulder arthroscopic surgery, regardless of gender, aged 65~85 years old, ASAI.~III. grade

Exclusion criteria

Exclusion criteria: (1) History of severe cardiovascular and cerebrovascular diseases such as cerebral infarction and myocardial infarction in the past six months; (2) history of previous dementia or psychiatric illness; (3) Patients who are unable to cooperate with the completion of the Mini-Mental State Examination (MMSE) or whose score is lower than the corresponding minimum score (illiterate <=17 points, primary school <=20 points, secondary school <=22 points, and university <=23 points); (4) Severe liver and kidney impairment; (5) Long-term alcoholics or psychotropic drug addicts; (6) Patients with moderate to severe anemia; (7) Severe visual or hearing impairment; (8) Patients with severe arrhythmia before surgery; (9) Refusal to participate in this study.

Design outcomes

Primary

MeasureTime frame
Regional cerebral oxygen saturation;Heart rate;Mean arterial pressure, MAP ;Sedation-agitation scale;Confusion assessment method;

Secondary

MeasureTime frame
Anesthesia duration;Surgery duration;PACU stay duration;Simple mental intelligence scale score;Total amount of anesthetic drugs;Numerical rating scale;

Countries

China

Contacts

Public ContactXianyu Wencui

Li Huili Hospital Affiliated to Ningbo University

nblhlxywc@163.com+86 187 6851 0967

Outcome results

None listed

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