Shenfu Injection for Postoperative Delirium (SFI for POD)

Not Applicable

• Conditions: Postoperative Delirium
• Interventions: Drug: Shen-Fu injection; Drug: normal saline

• Registration Number: NCT05179252
• Lead Sponsor: Shandong University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-16
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05
• Study Start: 2022-02-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SFI intervention group	Shen-Fu injection	shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop.
Control group	normal saline	same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop.

Primary Outcome Measures

Name	Time	Method
incidence of postoperative delirium within 7 days	day 1-7 after surgery, more scores means higher incidence of POD	postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.

Secondary Outcome Measures

Name	Time	Method
length of stay	approximately day 1 in hospital to day 7	length of hospital stay
all-caused mortality within 30 days	30 days after surgery	short-term follow up
non-delirium complications	day 1-7 after surgery	postoperative complications except for delirium
pain assessment within 3 days	day 1-3 after surgery, higher scores mean more pain.	postoperative pain estimated with Numerical Rating Scale
survival in 1 year	1 year discharge from hospital	long-term follow up
adverse events to shenfu injection	approximately day1-7 after surgery	adverse events caused form shenfu injection