Shenfu Injection for Postoperative Delirium (SFI for POD)

Postoperative Delirium Clinical Trial

— POD  

Official title:

POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05179252
• Other study ID #: SZYA20210603-A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: Shandong University of Traditional Chinese Medicine
• Contact: zhang weiliang
• Phone: 13365316885
• Email: hezhangweiliang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• Shen-Fu injection
Chinese patent medicine made by modern technology
• normal saline
0.9% normal saline, used for sham control

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University of Traditional Chinese Medicine	Shandong Institute of Science and Technology Information

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative delirium within 7 days	postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.	day 1-7 after surgery, more scores means higher incidence of POD
Secondary	non-delirium complications	postoperative complications except for delirium	day 1-7 after surgery
Secondary	length of stay	length of hospital stay	approximately day 1 in hospital to day 7
Secondary	pain assessment within 3 days	postoperative pain estimated with Numerical Rating Scale	day 1-3 after surgery, higher scores mean more pain.
Secondary	all-caused mortality within 30 days	short-term follow up	30 days after surgery
Secondary	survival in 1 year	long-term follow up	1 year discharge from hospital
Secondary	adverse events to shenfu injection	adverse events caused form shenfu injection	approximately day1-7 after surgery