Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

Traumatic Brain Injury Clinical Trial

Official title:

Study on the Improvement of Neurological Function and Prognostic Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients: a Single-Center Prospective Randomized Controlled Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06241482
• Other study ID #: In application process
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: Shanghai 6th People's Hospital
• Contact: Hao Chen, M.D., Ph.D.
• Phone: 8602164369181
• Email: hao.chen[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Traumatic Brain Injury

Intervention

Procedure:
• Enhanced recovery after surgery
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
Conventional therapy in neurocritical care.

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical prognosis	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)	One month, three and six months after injury or attack
Primary	Neurological function assessment	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)	One month, three and six months after injury or attack
Secondary	Neuroimaging evaluation	Computer tomography or magnetic resonance imaging	One week, two weeks after surgery; one month, three and six months after injury or attack