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NCT Number: NCT06241482

Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

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.

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Key information

Conditions

Neurocritical Care Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disease Cerebrovascular Disorders Coma Consciousness Disorders Craniocerebral Trauma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Moderate or Severe Coma Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Traumatic Brain Injury Unconsciousness Vascular Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai 6th People's Hospital

Shanghai, 200233, China

Location status: Recruiting

Location contact

Hao Chen, M.D., Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced recovery after surgery

Procedure

The technologies, processes and measures of enhanced recovery after surgery focus on the following aspects:

  • Early assessment and treatment
  • Optimized anesthetic protocol
  • Reducing surgical stress
  • Multi-modal comprehensive monitoring
  • Comprehensive diagnosis and treatment in neurosurgical intensive care
  • Intensive early rehabilitation treatment

Conventional Therapy

Procedure

Conventional therapy in neurocritical care.

Primary outcomes

  1. Clinical prognosis

    Time frame: 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)

  2. Neurological function assessment

    Time frame: 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 outcomes

  1. Neuroimaging evaluation

    Time frame: One week, two weeks after surgery; one month, three and six months after injury or attack

    Computer tomography or magnetic resonance imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Chen, M.D., Ph.D.

CONTACT

[email protected]

8602164369181 ext. 8405

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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