Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05179252
Other study ID # SZYA20210603-A1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 1, 2022

Study information

Verified date December 2021
Source Shandong University of Traditional Chinese Medicine
Contact zhang weiliang
Phone 13365316885
Email hezhangweiliang@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 350
Est. completion date December 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 75 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Shen-Fu injection
Chinese patent medicine made by modern technology
normal saline
0.9% normal saline, used for sham control

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shandong University of Traditional Chinese Medicine Shandong Institute of Science and Technology Information

Outcome

Type Measure Description Time frame Safety issue
Primary 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 non-delirium complications postoperative complications except for delirium day 1-7 after surgery
Secondary length of stay length of hospital stay approximately day 1 in hospital to day 7
Secondary pain assessment within 3 days postoperative pain estimated with Numerical Rating Scale day 1-3 after surgery, higher scores mean more pain.
Secondary all-caused mortality within 30 days short-term follow up 30 days after surgery
Secondary survival in 1 year long-term follow up 1 year discharge from hospital
Secondary adverse events to shenfu injection adverse events caused form shenfu injection approximately day1-7 after surgery
See also
  Status Clinical Trial Phase
Completed NCT03606941 - Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery N/A
Recruiting NCT05990790 - The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium Phase 4
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Completed NCT02585128 - Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation N/A
Recruiting NCT02227225 - Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Terminated NCT00455143 - Cognitive Protection - Dexmedetomidine and Cognitive Reserve Phase 4
Recruiting NCT05010148 - A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain Phase 3
Completed NCT06178835 - EPO for Postop Delirium in Elderly Patients Phase 4
Recruiting NCT05992506 - Electroencephalographic Biomarker to Predict Postoperative Delirium
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04154176 - Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity
Not yet recruiting NCT06375265 - Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients N/A
Recruiting NCT05572307 - Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Completed NCT01964274 - Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
Completed NCT01599689 - Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients N/A
Active, not recruiting NCT03291626 - Postoperative Delirium: EEG Markers of Sleep and Wakefulness