Back to resultsA Better Choice for Patients Undergoing Endovascular Coil Embolization
Primary Purpose
Intracranial Aneurysms
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sevoflurane and 0.5 μg/kg dexmedetomidine
sevoflurane and 1 μg/kg dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysms focused on measuring dexmedetomidine, endovascular coil embolization
Eligibility Criteria
Inclusion Criteria:18-65 years old ASA I or ASA II patients undergoing ECE treatment for intracranial aneurysms were included.
Exclusion Criteria:Patients were excluded based on the following parameters: older than 65 yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.
Sites / Locations
- Wen-fei Tan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
sevoflurane and saline infusion
sevoflurane and 0.5 μg/kg dexmedetomidine
sevoflurane and 1 μg/kg dexmedetomidine
Arm Description
After induction of general anesthesia, Group S received a placebo infusion of normal saline.
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Outcomes
Primary Outcome Measures
Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT01722409
First Posted
November 3, 2012
Last Updated
June 23, 2015
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT01722409
Brief Title
A Better Choice for Patients Undergoing Endovascular Coil Embolization
Official Title
Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
Keywords
dexmedetomidine, endovascular coil embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane and saline infusion
Arm Type
No Intervention
Arm Description
After induction of general anesthesia, Group S received a placebo infusion of normal saline.
Arm Title
sevoflurane and 0.5 μg/kg dexmedetomidine
Arm Type
Experimental
Arm Description
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
Arm Title
sevoflurane and 1 μg/kg dexmedetomidine
Arm Type
Experimental
Arm Description
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Intervention Type
Drug
Intervention Name(s)
sevoflurane and 0.5 μg/kg dexmedetomidine
Other Intervention Name(s)
DEX1
Intervention Description
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
Intervention Type
Drug
Intervention Name(s)
sevoflurane and 1 μg/kg dexmedetomidine
Other Intervention Name(s)
DEX2
Intervention Description
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Primary Outcome Measure Information:
Title
Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
Description
The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.
Time Frame
At the end of the operation and 24 hours later
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:18-65 years old ASA I or ASA II patients undergoing ECE treatment for intracranial aneurysms were included.
Exclusion Criteria:Patients were excluded based on the following parameters: older than 65 yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Ma, M.D.,PhD.
Organizational Affiliation
Dept. of Anesthesiology, the First Hospital of CMU
Official's Role
Study Chair
Facility Information:
Facility Name
Wen-fei Tan
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Better Choice for Patients Undergoing Endovascular Coil Embolization
We'll reach out to this number within 24 hrs