A Better Choice for Patients Undergoing Endovascular Coil Embolization
Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJune 25, 2015
October 1, 2013
2.2 years
November 3, 2012
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At the end of the operation and 24 hours later
Study Arms (3)
sevoflurane and saline infusion
NO INTERVENTIONAfter induction of general anesthesia, Group S received a placebo infusion of normal saline.
sevoflurane and 0.5 μg/kg dexmedetomidine
EXPERIMENTALAfter induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
sevoflurane and 1 μg/kg dexmedetomidine
EXPERIMENTALAfter induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wen-fei Tan
Shenyang, Liaoning, 110001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hong Ma, M.D.,PhD.
Dept. of Anesthesiology, the First Hospital of CMU
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 3, 2012
First Posted
November 6, 2012
Study Start
December 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
June 25, 2015
Record last verified: 2013-10