Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
Primary Purpose
Dexmedetomidine, Delirium, Awake Craniotomy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% saline
Sponsored by
About this trial
This is an interventional prevention trial for Dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing selective awake craniotomies.
- Age ≥18 years.
- Obtain written informed consent.
Exclusion Criteria:
- 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18).
- 2.Preoperative psychotropic medication within one year.
- 3.BMI≤18 or ≥30 Kg/ m2
- 4.Pregnant or lactating women.
- 5.History of traumatic brain injury or neurosurgery.
- 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
- 7.Severe hepatic or renal dysfunction.
Sites / Locations
- Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
DEX group
Placebo group
Arm Description
The DEX group patients will be received dexmedetomidine intraoperatively.
The placebo group patients will be received 0.9% saline intraoperatively.
Outcomes
Primary Outcome Measures
The incidence of postoperative delirium.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05195034
First Posted
January 4, 2022
Last Updated
November 7, 2022
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05195034
Brief Title
Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
Official Title
Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Postoperative delirium (POD) is a common complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Delirium, Awake Craniotomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEX group
Arm Type
Active Comparator
Arm Description
The DEX group patients will be received dexmedetomidine intraoperatively.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group patients will be received 0.9% saline intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
The 0.9% saline is administered with the same volume at the same speed as the other group.
Primary Outcome Measure Information:
Title
The incidence of postoperative delirium.
Description
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.
Time Frame
postoperative 5 day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing selective awake craniotomies.
Age ≥18 years.
Obtain written informed consent.
Exclusion Criteria:
1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18).
2.Preoperative psychotropic medication within one year.
3.BMI≤18 or ≥30 Kg/ m2
4.Pregnant or lactating women.
5.History of traumatic brain injury or neurosurgery.
6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
7.Severe hepatic or renal dysfunction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuming Peng, MD,Ph.D
Phone
8610-59976658
Email
florapym766@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, MD,Ph.D
Organizational Affiliation
Beijing Tian Tan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100160
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Peng
Phone
8610-59976658
Email
florapym766@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
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