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A Better Choice for Patients Undergoing Endovascular Coil Embolization

This study is currently recruiting participants.
Verified April 2013 by China Medical University, China
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China
ClinicalTrials.gov Identifier:
NCT01722409
First received: November 3, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Intracranial Aneurysms
 Drug: sevoflurane and 0.5 μg/kg dexmedetomidine
Drug: sevoflurane and 1 μg/kg dexmedetomidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by China Medical University, China:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722409

Contacts
Contact: Wen-fei Tan, M.D.,PhD 8602483283100 winfieldtan@hotmail.com

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

No publications provided

Responsible Party: Wen-fei Tan, Associate professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT01722409     History of Changes
Other Study ID Numbers: 20121009
Study First Received: November 3, 2012
Last Updated: April 29, 2013
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
dexmedetomidine, endovascular coil embolization

Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sevoflurane
Dexmedetomidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on May 22, 2013