Shenfu Injection for Postoperative Delirium (SFI for POD)

NCT ID: NCT05179252

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SFI intervention group

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

Group Type EXPERIMENTAL

Shen-Fu injection

Intervention Type DRUG

Chinese patent medicine made by modern technology

Control group

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

Group Type SHAM_COMPARATOR

normal saline

Intervention Type DRUG

0.9% normal saline, used for sham control

Interventions

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Shen-Fu injection

Chinese patent medicine made by modern technology

Intervention Type DRUG

normal saline

0.9% normal saline, used for sham control

Intervention Type DRUG

Other Intervention Names

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sanjiu yaan physiological saline solution

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Institute of Science and Technology Information

OTHER

Sponsor Role collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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weiliang zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zhang xin

Role: STUDY_DIRECTOR

Shandong University of Traditional Chinese Medicine

Central Contacts

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zhang weiliang

Role: CONTACT

13365316885

zhang xin

Role: CONTACT

0531-68616733

Other Identifiers

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SZYA20210603-A1

Identifier Type: -

Identifier Source: org_study_id

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