Back to resultsDexmedetomidine Improves Recovery After Cranial Aneurysm Surgery (DACA)
Primary Purpose
Aneurysm Cerebral
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intravenous dexmedetomidine
nasal dexmedetomidine
intravenous saline
nasal saline
Sponsored by
About this trial
This is an interventional prevention trial for Aneurysm Cerebral focused on measuring dexmedetomidine, general anesthesia, cerebral aneurysm
Eligibility Criteria
Inclusion Criteria:
- patients undergoing cerebral aneurysm embolism under general anesthesia
Exclusion Criteria:
- patients with bradycardia or atrioventricular heart block
- patients with ASA(American Society of Anesthesiologists) status over 3
- patients with body mass index(BMI)≥30kg/m2
- patients with difficulty in communication
- patients with ruptured aneurysm
- patients suspected or proved to be pregnant
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
nasal dexmedetomidine
intravenous dexmedetomidine
normal saline
Arm Description
dexmedetomidine is given nasally, saline is given intravenously
saline is given nasally, dexmedetomidine is given intravenously
saline is given nasally and intravenously
Outcomes
Primary Outcome Measures
incidence of coughing
Secondary Outcome Measures
Ricker's agitation-sedation score
score of coughing
0=no coughing;1=intermittent coughing;2=continuous coughing
time to response to verbal command
time to extubation
blood pressure before and after extubation
blood glucose before and after aneurysm embolism
blood lactate before and after aneurysm embolism
Mini-mental state examination score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03355534
Brief Title
Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery
Acronym
DACA
Official Title
Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhihong LU
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm Cerebral
Keywords
dexmedetomidine, general anesthesia, cerebral aneurysm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nasal dexmedetomidine
Arm Type
Experimental
Arm Description
dexmedetomidine is given nasally, saline is given intravenously
Arm Title
intravenous dexmedetomidine
Arm Type
Experimental
Arm Description
saline is given nasally, dexmedetomidine is given intravenously
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
saline is given nasally and intravenously
Intervention Type
Drug
Intervention Name(s)
Intravenous dexmedetomidine
Intervention Description
drug is intravenously infused to patients
Intervention Type
Drug
Intervention Name(s)
nasal dexmedetomidine
Intervention Description
drug is nasally given to patients
Intervention Type
Drug
Intervention Name(s)
intravenous saline
Intervention Description
saline is given to patients intravenously
Intervention Type
Drug
Intervention Name(s)
nasal saline
Intervention Description
normal saline is given to patients nasally
Primary Outcome Measure Information:
Title
incidence of coughing
Time Frame
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Secondary Outcome Measure Information:
Title
Ricker's agitation-sedation score
Time Frame
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Title
score of coughing
Description
0=no coughing;1=intermittent coughing;2=continuous coughing
Time Frame
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Title
time to response to verbal command
Time Frame
from end of infusing anesthetics to response to verbal command,averagely 20 minutes
Title
time to extubation
Time Frame
from end of infusing anesthetics to extubation,averagely 28 minutes
Title
blood pressure before and after extubation
Time Frame
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
Title
blood glucose before and after aneurysm embolism
Time Frame
immediately before inserting coil and after finishing inserting coil,an average of 1 hour
Title
blood lactate before and after aneurysm embolism
Time Frame
immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
Title
Mini-mental state examination score
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing cerebral aneurysm embolism under general anesthesia
Exclusion Criteria:
patients with bradycardia or atrioventricular heart block
patients with ASA(American Society of Anesthesiologists) status over 3
patients with body mass index(BMI)≥30kg/m2
patients with difficulty in communication
patients with ruptured aneurysm
patients suspected or proved to be pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lize Xiong
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24974190
Citation
Peng K, Wu S, Liu H, Ji F. Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: meta-analysis of randomized controlled trials. J Clin Neurosci. 2014 Nov;21(11):1951-8. doi: 10.1016/j.jocn.2014.02.023. Epub 2014 Jun 25.
Results Reference
result
PubMed Identifier
21991729
Citation
Soliman RN, Hassan AR, Rashwan AM, Omar AM. Prospective, randomized controlled study to assess the role of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anesthesia. Middle East J Anaesthesiol. 2011 Feb;21(1):23-33.
Results Reference
result
PubMed Identifier
28631453
Citation
Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017 Dec;83(12):1248-1254. doi: 10.23736/S0375-9393.17.11873-0. Epub 2017 Jun 14.
Results Reference
result
PubMed Identifier
28639236
Citation
Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
Results Reference
result
PubMed Identifier
28470100
Citation
Sun Y, Li Y, Sun Y, Wang X, Ye H, Yuan X. Dexmedetomidine Effect on Emergence Agitation and Delirium in Children Undergoing Laparoscopic Hernia Repair: a Preliminary Study. J Int Med Res. 2017 Jun;45(3):973-983. doi: 10.1177/0300060517699467. Epub 2017 Mar 21.
Results Reference
result
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Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery
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