Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections
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|ClinicalTrials.gov Identifier: NCT04674241|
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : March 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dexmedetomidine Postoperative Delirium||Drug: Dexmedetomidine Drug: 0.9% saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study|
|Actual Study Start Date :||January 18, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: DEX group
The DEX group will receives dexmedetomidine intraoperative.
200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/min until the dura is beginning to be sutured.
Placebo Comparator: Placebo group
The placebo group will receives 0.9% saline intraoperative.
Drug: 0.9% saline
0.9% saline is administered with the same volume at the same speed as the other group.
- The incidence of postoperative delirium [ Time Frame: postoperative 5 day ]
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.
Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present.
In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674241
|Contact: Yuming Peng, MD,Ph.Demail@example.com|
|Beijing TianTan Hospital||Recruiting|
|Beijing, Beijing,China, China, 100070|
|Contact: Yuming Peng, MD,Ph.D firstname.lastname@example.org|
|Principal Investigator:||Yu Ming Peng, MD,Ph.D||Beijing Tian Tan Hospital|