Application of Early Goal-directed Sedation in Patients With Severe Brain Injury

Brain Injuries, Traumatic Clinical Trial

Official title:

Application of Early Goal-directed Sedation in Patients With Severe Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525482
• Other study ID #: 2017-081
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

EGDS management strategy was implemented in ICU patients with severe brain injury, the depth of sedation and GCS score were monitored, and the protective effects of EGDS strategy and standard sedation strategy on the brain of patients with severe brain injury were discussed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of severe craniocerebral injury

• The GCS score is 6 to 12 points

• Within 12 hours of intubation

• The mechanical ventilation time is greater than 24 hours

• Obtain written consent

Exclusion Criteria:

• Pregnant women

• Acute liver failure

• Dementia or mental illness

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Other:
• Early goal-directed sedation programs
A. Provide sedation at the beginning of the titration of dextrometomidine; b. Optimize sedation when dextrometomidine is used alone and at a maximum dose not sufficient to provide comfort and safety to the patient and to achieve a level of sedation at any time specified by the treating physician. C. Provides immediate recovery and sedation, and can control sudden agitation at any time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Richmond Agitation-Sedation Scale		through study completion, an average of 2 year
Primary	Mechanical ventilation time		through study completion, an average of 2 year
Primary	length of stay in ICU		through study completion, an average of 2 year
Secondary	complication		through study completion, an average of 2 year