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A multicenter randomized controlled trial on the impact of high-volume fluid loading before anesthetic induction on postoperative delirium (POD)

A multicenter randomized controlled trial on the impact of high-volume fluid loading before anesthetic induction on postoperative delirium (POD)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101972
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-05-10
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Postoperative delirium

Interventions

Experimental group:Infusion of crystalloid solution at 12 ml/kg within 1 hour prior to anesthesia induction
Control group :Infusion of crystalloid solution at 2.5 ml/kg within 1 hour prior to anesthesia induction.

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1 Patients aged 65 years and older, of any gender; 2 Patients with ASA classification of I-III; 3 Patients scheduled for elective non-cardiac and non-neurosurgical procedures; 4 Patients with no communication barriers and able to comply with all protocols during the trial.

Exclusion criteria

Exclusion criteria: 1 History of neurological diseases, dementia, or other psychiatric disorders; 2 Preoperative MMSE score less than 20; 3 History of severe auditory, visual, or motor impairments; 4 Patients with preoperative delirium; 5 Hematocrit (Hct) < 30% or hemoglobin (Hb) < 10 g/L; 6 History of allergy to hydroxyethyl starch or gelatin; 7 Significant heart, liver, or kidney dysfunction, or coagulation abnormalities; 8 Illiteracy or communication barriers; 9 Recent participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
the incidence of postoperative delirium;

Secondary

MeasureTime frame
the severity of postoperative delirium;the types of postoperative delirium ;the duration of postoperative delirium;sleep quality assessment;postoperative pain score;cognitive function assessment;physical function assessment;frailty assessment;incidence of postoperative nausea and vomiting;postoperative recovery quality score;length of hospital stay;30-day mortality rate;Mini-Mental State Examination;Short IQ Test;postoperative adverse events record;intraoperative adverse events record;

Countries

China

Contacts

Public ContactYingwei Wang

Huashan Hospital Affiliated to Fudan University

wangyw@fudan.edu.cn+86 139 1869 0528

Outcome results

None listed

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