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Recruiting NCT06241482

Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

No phase Interventional Neurocritical Care Traumatic Brain Injury Cerebrovascular Disease Moderate or Severe Coma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced recovery after surgery, Conventional therapy.
Who it may be relevant to
Registry conditions: Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease, Moderate or Severe Coma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients

Overview

Enhanced recovery after surgery (ERAS) is a strategy of perioperative management aimed to accelerate the rehabilitation of patients through various optimized perioperative managements as well as ongoing adherence to a patient-focused, multidisciplinary, and multimodal approach. Alleviating the injury and stress caused by surgery or disease is the core principle of ERAS, which has been shown to reduce complication rates after surgery, promote patient recovery, decrease hospital length of stay and reduce costs. ERAS has been widely applied in many surgical perioperative fields, and it has achieved remarkable effects. However, there are few applications of ERAS in neurosurgery, especially in clinical trials of neurocritical care patients. Therefore, the investigators attempt to conduct the study of ERAS in neurosurgical intensive patients using a series of optimized perioperative managements that have been verified to be effective by evidence-based medicine, and to evaluate the safety and effectiveness of ERAS in neurocritical care. The aim of this study is to explore the most suitable ERAS protocols to accelerate the postoperative rehabilitation process of neurocritical care patients, and to provide more evidence-based medicine for the effectiveness and safety of ERAS in neurosurgery.

Interventions

  • Procedure Enhanced recovery after surgery
    The technologies, processes and measures of enhanced recovery after surgery focus on the following aspects: 1. Early assessment and treatment 2. Optimized anesthetic protocol 3. Reducing surgical stress 4. Multi-modal comprehensive monitoring 5. Comprehensive diagnosis and treatment in neurosurgical intensive care 6. Intensive early rehabilitation treatment
  • Procedure Conventional therapy
    Conventional therapy in neurocritical care.

Primary outcome measures

  • Clinical prognosis [Time frame: One month, three and six months after injury or attack]
  • Neurological function assessment [Time frame: One month, three and six months after injury or attack]
Secondary outcome measures (1)
  • Neuroimaging evaluation [Time frame: One week, two weeks after surgery; one month, three and six months after injury or attack]

Eligibility criteria

Inclusion criteria

  • Age 18-75 years old
  • Patients with moderate or severe acute traumatic brain injury or cerebrovascular disease requiring neurosurgical intensive care treatment
  • Hospitalization time ≥ 1 week
  • The guardian is able to understand and actively cooperate in completing the project
  • The guardian signs an informed consent form

Exclusion criteria

  • Patients undergoing non-surgical treatment
  • Patients diagnosed as brain death within the first 24 hours after admission to NICU
  • Patients undergoing cardiopulmonary resuscitation, maintenance dialysis, end-stage tumors, and disseminated cancer
  • Patients who withdraw treatment during hospitalization or are discharged automatically
  • Patients who underwent unplanned secondary surgery during the research process
  • Individuals who cannot be followed up during the research process

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai 6th People's Hospital — Shanghai

Identifiers

NCT: NCT06241482 · 2024-179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗