Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06241482
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai 6th People's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hao Chen, M.D., Ph.D.
Principal Investigator Affiliation Shanghai 6th Peoples' Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease, Moderate or Severe Coma
Arms & Interventions

Arms

Experimental: Enhanced recovery after surgery

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

Active Comparator: Conventional therapy

Conventional therapy were applied.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai 6th People's Hospital, Shanghai 1796236, China

Status

Recruiting

Address

Shanghai 6th People's Hospital

Shanghai 1796236, , 200233

Site Contact

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

[email protected]

8602164369181

Stay Informed & Connected