Back to resultsDexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
Primary Purpose
Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring Dexmedetomidine, brain arteriovenous malformation, embolization, post-operative hypertension
Eligibility Criteria
Inclusion Criteria:
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
Sites / Locations
- the First Affiliated Hospital of Sun Yetsen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Control group
Arm Description
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
Outcomes
Primary Outcome Measures
urapidil consumption
urapidil consumption was recorded by nurses every hour
Secondary Outcome Measures
urapidil consumption on POD1
urapidil consumption was recorded by nurses every hour
urapidil consumption on POD2
urapidil consumption was recorded by nurses every hour
Visual Analogue score
visual analogue score was measured by visual analogue scale
Visual Analogue score at 24th hour
visual analogue score was measured by visual analogue scale
Visual Analogue score at 48th hour
visual analogue score was measured by visual analogue scale
Quality of Recovery Score
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Quality of Recovery Score at 24th hour
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Quality of Recovery Score at 48th hour
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Analgesics consumption
Analgesics consumption was recorded by nurse every hour
Analgesics consumption on POD1
Analgesics consumption was recorded by nurse every hour
Analgesics consumption on POD2
Analgesics consumption was recorded by nurse every hour
Bradycardia
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Bradycardia at 24th hour
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Bradycardia at 48th hour
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
PONV
post-operative nausea and vomiting (PONV) was recorded by nurse
PONV at 24th hour
post-operative nausea and vomiting (PONV) was recorded by nurse
PONV at 48th hour
post-operative nausea and vomiting (PONV) was recorded by nurse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03076099
Brief Title
Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
Official Title
Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nan Jiang
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
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
Detailed Description
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
Keywords
Dexmedetomidine, brain arteriovenous malformation, embolization, post-operative hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two parallel groups
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
this investigation is a triple mask study. The patiens, the care providers and Outcome Assessor will not allowed to know the grouping information.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DEX
Intervention Description
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Intervention Type
Other
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Intervention Description
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Primary Outcome Measure Information:
Title
urapidil consumption
Description
urapidil consumption was recorded by nurses every hour
Time Frame
the end of the 6th hour after tracheal extubation
Secondary Outcome Measure Information:
Title
urapidil consumption on POD1
Description
urapidil consumption was recorded by nurses every hour
Time Frame
the total consumption of urapidil on post-operative day 1.
Title
urapidil consumption on POD2
Description
urapidil consumption was recorded by nurses every hour
Time Frame
the total consumption of urapidil on post-operative day 2.
Title
Visual Analogue score
Description
visual analogue score was measured by visual analogue scale
Time Frame
the end of the 6th hour after tracheal extubation
Title
Visual Analogue score at 24th hour
Description
visual analogue score was measured by visual analogue scale
Time Frame
the end of the 24th hour after tracheal extubation
Title
Visual Analogue score at 48th hour
Description
visual analogue score was measured by visual analogue scale
Time Frame
the end of the 48th hour after tracheal extubation
Title
Quality of Recovery Score
Description
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Time Frame
the end of the 6th hour after tracheal extubation
Title
Quality of Recovery Score at 24th hour
Description
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Time Frame
the end of the 24th hour after tracheal extubation
Title
Quality of Recovery Score at 48th hour
Description
Quality of Recovery Score was measured by a 15-item quality of recovery scale
Time Frame
the end of the 48th hour after tracheal extubation
Title
Analgesics consumption
Description
Analgesics consumption was recorded by nurse every hour
Time Frame
the end of the 6th hour after tracheal extubation
Title
Analgesics consumption on POD1
Description
Analgesics consumption was recorded by nurse every hour
Time Frame
the total consumption of urapidil on post-operative day 1.
Title
Analgesics consumption on POD2
Description
Analgesics consumption was recorded by nurse every hour
Time Frame
the total consumption of urapidil on post-operative day 2.
Title
Bradycardia
Description
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Time Frame
the end of the 6th hour after tracheal extubation
Title
Bradycardia at 24th hour
Description
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Time Frame
the end of the 24th hour after tracheal extubation
Title
Bradycardia at 48th hour
Description
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
Time Frame
the end of the 48th hour after tracheal extubation
Title
PONV
Description
post-operative nausea and vomiting (PONV) was recorded by nurse
Time Frame
the end of the 6th hour after tracheal extubation
Title
PONV at 24th hour
Description
post-operative nausea and vomiting (PONV) was recorded by nurse
Time Frame
the end of the 24th hour after tracheal extubation
Title
PONV at 48th hour
Description
post-operative nausea and vomiting (PONV) was recorded by nurse
Time Frame
the end of the 48th hour after tracheal extubation
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 brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Jiang, PhD
Phone
86 20 28823350
Email
NJiang_sysu@126.com
Facility Information:
Facility Name
the First Affiliated Hospital of Sun Yetsen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Liu, Master
Phone
+86 13632391455
Email
liuyisysu@126.com
First Name & Middle Initial & Last Name & Degree
Nan Jiang, professor
Phone
+86 20 28823350
Email
NJiang_sysu@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the IPD will not be shared with others, since following investigations based on this trial is about to start.
Learn more about this trial
Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
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