Shenfu Injection for Postoperative Delirium (SFI for POD) (POD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Shen-Fu injection; Drug: normal saline

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 Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zhang weiliang; Phone Number: 13365316885; Email: hezhangweiliang@163.com
• Study Contact Backup: Name: zhang xin; Phone Number: 0531-68616733

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SFI intervention group; shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop.	Drug: Shen-Fu injection; Chinese patent medicine made by modern technology; Other Names: sanjiu yaan
Sham Comparator: Control group; same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop.	Drug: normal saline; 0.9% normal saline, used for sham control; Other Names: physiological saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University of Traditional Chinese Medicine
• Collaborators: Shandong Institute of Science and Technology Information
• Investigators: Study Director: zhang xin, Shandong University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: SZYA20210603-A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No