Shenfu Injection for Postoperative Delirium (SFI for POD)

NCT05179252 | Unknown DMC

• 1 other identifier: SZYA20210603-A1
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• non-delirium complications

  day 1-7 after surgery

• length of stay

  approximately day 1 in hospital to day 7

• pain assessment within 3 days

  day 1-3 after surgery, higher scores mean more pain.

• all-caused mortality within 30 days

  30 days after surgery

• survival in 1 year

  1 year discharge from hospital

Study Arms (2)

SFI intervention group

EXPERIMENTAL

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

Drug: Shen-Fu injection

Control group

SHAM COMPARATOR

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

Drug: normal saline

Interventions

Shen-Fu injection DRUG

Chinese patent medicine made by modern technology

Also known as: sanjiu yaan

SFI intervention group

normal saline DRUG

0.9% normal saline, used for sham control

Also known as: physiological saline solution

Control group

Eligibility Criteria

• Age: 75 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• hip fracture surgery under epidural anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Shandong University of Traditional Chinese Medicine: lead
• Shandong Institute of Science and Technology Information: collaborator

MeSH Terms

Conditions

Emergence Delirium

Interventions

Shen-Fu; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• zhang xin

  Shandong University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

zhang weiliang

CONTACT

13365316885; hezhangweiliang@163.com

zhang xin

CONTACT

0531-68616733

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 5, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share