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Clinical Trials/NCT05304559
NCT05304559
Unknown
Not Applicable

Effects of S-ketamine and Continuous Iliac Fascia Space Block on Perioperative Neurological Cognitive Impairment and Postoperative Rehabilitation in Elderly Patients With Hip Fracture

Yangzhou University1 site in 1 country108 target enrollmentMarch 26, 2022

Overview

Phase
Not Applicable
Intervention
S-Ketamine
Conditions
Hip Fractures
Sponsor
Yangzhou University
Enrollment
108
Locations
1
Primary Endpoint
incidence of peioperative neurocognitive impairment
Last Updated
4 years ago

Overview

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.

Detailed Description

With the advent of the aging society, the incidence of hip fracture in elderly patients is increasing year by year, and the incidence of perioperative neurological cognitive impairment (PND) is increasing year by year. PND refers to postoperative brain dysfunction in patients without mental disorders, including postoperative delirium POD and postoperative cognitive dysfunction POCD. PND is more common in clinic, especially in the elderly. The main feature of PND is the long-term decline and decline of cognitive function after operation. PND not only prolongs the length of stay of patients, interferes with postoperative treatment, but even increases mortality. The pathogenesis of PND is not clear, and it is affected by many factors. Studies have shown that keeping intraoperative blood pressure at baseline to 10% above baseline can significantly reduce the incidence of PND. In addition, pain is also an important factor leading to the occurrence of PND. 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. 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. In this study, a randomized controlled trial was conducted to observe the clinical effects of S-ketamine and ultrasound-guided iliac fascia block combined with general anesthesia in elderly patients with hip fracture, and to evaluate their clinical value.

Registry
clinicaltrials.gov
Start Date
March 26, 2022
End Date
January 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yangzhou University
Responsible Party
Principal Investigator
Principal Investigator

Yangtian Shuang

Resident physician

Yangzhou University

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of hip fracture
  • Aged 65 or above
  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

Drug group

S-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.

Intervention: S-Ketamine

Device group

The 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.

Intervention: Continuous iliac fascia space block

Normal saline group

normal 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.

Intervention: Normal saline

Outcomes

Primary Outcomes

incidence of peioperative neurocognitive impairment

Time Frame: Perioperative period

incidence of peioperative neurocognitive impairment

Study Sites (1)

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