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

NCT ID: NCT04525482

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

No intervention was implemented

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Early goal-directed sedation programs was implemented

Group Type: EXPERIMENTAL

Early goal-directed sedation programs

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2017-081

Identifier Type: -

Identifier Source: org_study_id