Shenfu Injection for Postoperative Delirium (SFI for POD)

Shandong University of Traditional Chinese Medicine

Status: Unknown

Conditions: Postoperative Delirium

Treatments: Drug: normal saline; Drug: Shen-Fu injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05179252

SZYA20210603-A1

Details and patient eligibility

About

Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.

Full description

SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.

Enrollment: 350 estimated patients

Sex: All

Ages: 75 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hip fracture surgery under epidural anesthesia

Exclusion criteria

• Severe dementia, hearing/vision impairment, coma, etc., unable to communicate;
• patients with end-stage diseases such as tumor;
• 3 months after myocardial infarction, cerebral infarction;
• severe heart, liver and renal dysfunction.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups

SFI intervention group

Experimental group

Description:

shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop.

Treatment:

Drug: Shen-Fu injection

Control group

Sham Comparator group

Description:

same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop.

Treatment:

Drug: normal saline