Skip to content

Perioperative stress regulation and organ function protection in Chinese medicine——Effect of Shenfu injection on patients with perioperative frailty

Perioperative stress regulation and organ function protection in Chinese medicine——Effect of Shenfu injection on patients with perioperative frailty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086046
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-07-20
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

perioperative frailty

Interventions

Intervention group:Preoperative application of Shenfu injection (diluted with dextrose injection)
Control group:Preoperative application of glucose injection

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? general anesthesia surgery patients aged 18-75 years old, BMI unlimited, patients preoperatively meet the diagnosis of frailty (EFS = 5 or CFS = 6); ? orthopaedic surgery indications are clear; ? ASA (American Society of Anesthesiologists) classification of ? - ?, cardiac, pulmonary, hepatic, renal function without significant abnormalities; ? no serious preoperative visual and auditory, cognitive, communication disorders; ? patients and their families are fully informed of this study and can cooperate with this study voluntarily.

Exclusion criteria

Exclusion criteria: ? people with dementia, schizophrenia or severe visual, auditory, speech disorders and other central nervous system diseases resulting in cognitive dysfunction, history of psychiatric disease-related drugs; ? people with heart, liver, kidney and other organ dysfunction or history of cardiovascular, respiratory and other major surgery and coagulation mechanism disorders; ? people with narcotic analgesic drug abuse or dependence; ? history of allergy to anesthesia or contraindications to ginseng injection as well as Patients with diabetes mellitus (Shenfu Injection diluted with glucose injection).

Design outcomes

Primary

MeasureTime frame
Awakening irritation;Delayed awakening;postoperative nausea and vomiting;Postoperative delirium;postoperative digestive disorder;

Secondary

MeasureTime frame
Edmonton frail scale scores at 1 d preoperatively and 3 d and 7 d postoperatively;Clinical frailty scale Classification;Mini Nutritiona Assessment preoperatively, 1 d postoperatively, and 3 d and 7 d postoperatively;Pittsburgh Sleep Quality Index preoperatively, 1 d postoperatively, and 3 d and 7 d postoperatively;

Countries

China

Contacts

Public ContactSu Fan

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

boatsail@126.com+86 131 5601 0810

Outcome results

None listed

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