Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Neurocritical Care; Traumatic Brain Injury; Cerebrovascular Disease; Moderate or Severe Coma

Treatments: Procedure: Enhanced recovery after surgery; Procedure: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06241482

2024-179

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Enhanced recovery after surgery

Experimental group

Description:

The technologies, processes and measures of enhanced recovery after surgery were applied.

Treatment:

Procedure: Enhanced recovery after surgery

Conventional therapy

Active Comparator group

Description:

Conventional therapy were applied.

Treatment:

Procedure: Conventional therapy