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A Better Choice for Patients Undergoing Endovascular Coil Embolization

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ClinicalTrials.gov Identifier: NCT01722409
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysms Drug: sevoflurane and 0.5 μg/kg dexmedetomidine Drug: sevoflurane and 1 μg/kg dexmedetomidine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization
Study Start Date : December 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: sevoflurane and saline infusion
After induction of general anesthesia, Group S received a placebo infusion of normal saline.
Experimental: sevoflurane and 0.5 μg/kg dexmedetomidine
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
Drug: sevoflurane and 0.5 μg/kg dexmedetomidine
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
Other Name: DEX1
Experimental: sevoflurane and 1 μg/kg dexmedetomidine
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Drug: sevoflurane and 1 μg/kg dexmedetomidine
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
Other Name: DEX2



Primary Outcome Measures :
  1. Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization. [ Time Frame: At the end of the operation and 24 hours later ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722409


Locations
China, Liaoning
Wen-fei Tan
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
Study Chair: Hong Ma, M.D.,PhD. Dept. of Anesthesiology, the First Hospital of CMU

Responsible Party: Wen-fei Tan, Associate professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT01722409     History of Changes
Other Study ID Numbers: 20121009
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: October 2013

Keywords provided by Wen-fei Tan, China Medical University, China:
dexmedetomidine, endovascular coil embolization

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Sevoflurane
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General