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Shenfu Injection for Postoperative Delirium (SFI for POD)

Sponsor
Shandong University of Traditional Chinese Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05179252
Collaborator
Shandong Institute of Science and Technology Information (Other)
350
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Shen-Fu injection
  • Drug: normal saline
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. non-delirium complications [day 1-7 after surgery]

      postoperative complications except for delirium

    2. length of stay [approximately day 1 in hospital to day 7]

      length of hospital stay

    3. pain assessment within 3 days [day 1-3 after surgery, higher scores mean more pain.]

      postoperative pain estimated with Numerical Rating Scale

    4. all-caused mortality within 30 days [30 days after surgery]

      short-term follow up

    5. survival in 1 year [1 year discharge from hospital]

      long-term follow up

    6. adverse events to shenfu injection [approximately day1-7 after surgery]

      adverse events caused form shenfu injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Study Director: zhang xin, Shandong University of Traditional Chinese Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    weiliang zhang, Principal Investigator, Shandong University of Traditional Chinese Medicine
    ClinicalTrials.gov Identifier:
    NCT05179252
    Other Study ID Numbers:
    • SZYA20210603-A1
    First Posted:
    Jan 5, 2022
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of Jan 5, 2022