Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury; Neurocritical Care; Cerebrovascular Disease; Moderate or Severe Coma
• Interventions: Procedure: Enhanced recovery after surgery; Procedure: Conventional therapy

• Registration Number: NCT06241482
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-27
• Study First Posted: 2024-02-05
• Study Start: 2024-10-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced recovery after surgery	Enhanced recovery after surgery	The technologies, processes and measures of enhanced recovery after surgery were applied.
Conventional therapy	Conventional therapy	Conventional therapy were applied.

Primary Outcome Measures

Name	Time	Method
Clinical prognosis	One month, three and six months after injury or attack	Glasgow Outcome Scale score (1 = death; 2 = persistent vegetative state; 3 = severe disability; 4 = moderate disability; 5 = good but not necessarily complete recovery; unfavorable outcome was defined as score of ≤3, and favorable outcome was defined as a score of \>3)
Neurological function assessment	One month, three and six months after injury or attack	Modified Rankin scale score (0 = no symptoms; 1 = no significant disability; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = dead; favorable outcome was defined as score of 0-2, and unfavorable outcome was defined as score of 3-6)

Secondary Outcome Measures

Name	Time	Method
Neuroimaging evaluation	One week, two weeks after surgery; one month, three and six months after injury or attack	Computer tomography or magnetic resonance imaging

Trial Locations

Locations (1)

Shanghai 6th People's Hospital; 🇨🇳 Shanghai, China