Effects of S-ketamine and Continuous Iliac Fascia Space Block on Perioperative Neurological Cognitive Impairment and Postoperative Rehabilitation in Elderly Patients With Hip Fracture
1 other identifier
interventional
108
1 country
1
Brief Summary
Elderly patients with hip fracture are older and have a high incidence of perioperative complications. the postoperative recovery of elderly patients with hip fracture is affected by hemodynamic instability and pain caused by fracture. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable in elderly patients with hip fracture.Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. It can more effectively reduce the perioperative pain of elderly patients with hip fracture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2022
CompletedStudy Start
First participant enrolled
March 26, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedMarch 31, 2022
March 1, 2022
1 month
March 1, 2022
March 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of peioperative neurocognitive impairment
incidence of peioperative neurocognitive impairment
Perioperative period
Study Arms (3)
Drug group
EXPERIMENTALS-ketamine 0.1mg/kg was injected intravenously during anesthesia induction and esmolamine 0.1mg/ (kg.h) was injected intravenously during anesthesia maintenance.S-Ketamine was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
Device group
EXPERIMENTALThe hip fracture was diagnosed clinically on admission and ultrasound-guided iliofascial space block was performed after evaluation, and the analgesia lasted until 2 days after operation.
Normal saline group
PLACEBO COMPARATORnormal saline 0.1ml/kg was injected intravenously during anesthesia induction and normal saline 0.1ml/ (kg.h) was injected intravenously during anesthesia maintenance.normal saline was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
Interventions
S-Ketamine0.1mg/kg was injected intravenously during anesthesia induction and S-Ketamine0.1mg/ (kg.h) was injected intravenously during anesthesia maintenance.S-Ketamine was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
After admission, the iliac fascia space block and catheterization were performed under the guidance of ultrasound, and the analgesia was continued until two days after operation.
Normal saline0.1ml/kg was injected intravenously during anesthesia induction and Normal saline0.1ml/ (kg.h) was injected intravenously during anesthesia maintenance.Normal saline was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of hip fracture
- Aged 65 or above
- ASA Ⅰ-Ⅲ
- No mental and nervous system diseases
- No pathological fractures, such as bone tumor, bone tuberculosis, osteomyelitis, etc
- No puncture site infection
- No hospital stay for more than 48 hours after operation
You may not qualify if:
- Patients with severe cardiac, hepatic and renal dysfunction before operation
- Long-term use of analgesics, sedatives and alcoholism
- Patients with respiratory tract management difficulties (modified Ma's score is IV)
- Previous neuropsychiatric diseases such as severe cerebrovascular, Alzheimer's disease, epilepsy and Parkinson's disease
- Previous history of intracranial surgery or craniocerebral injury
- Severe vision, hearing, language impairment or other reasons unable to communicate
- Allergic or contraindicated to ropivacaine or non-steroidal anti-inflammatory drugs (NSAID)
- Emergency surgery or trauma patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Yangzhou University
Yangzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
jJianhong Sun, master
Yangzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident physician
Study Record Dates
First Submitted
March 1, 2022
First Posted
March 31, 2022
Study Start
March 26, 2022
Primary Completion
April 26, 2022
Study Completion
January 31, 2023
Last Updated
March 31, 2022
Record last verified: 2022-03