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Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery (DACA)

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ClinicalTrials.gov Identifier: NCT03355534
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Zhihong LU, Fourth Military Medical University

Brief Summary:
Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.

Condition or disease Intervention/treatment Phase
Aneurysm Cerebral Drug: Intravenous dexmedetomidine Drug: nasal dexmedetomidine Drug: intravenous saline Drug: nasal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nasal dexmedetomidine
dexmedetomidine is given nasally, saline is given intravenously
Drug: nasal dexmedetomidine
drug is nasally given to patients

Drug: intravenous saline
saline is given to patients intravenously

Experimental: intravenous dexmedetomidine
saline is given nasally, dexmedetomidine is given intravenously
Drug: Intravenous dexmedetomidine
drug is intravenously infused to patients

Drug: nasal saline
normal saline is given to patients nasally

Placebo Comparator: normal saline
saline is given nasally and intravenously
Drug: intravenous saline
saline is given to patients intravenously

Drug: nasal saline
normal saline is given to patients nasally




Primary Outcome Measures :
  1. incidence of coughing [ Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes ]

Secondary Outcome Measures :
  1. Ricker's agitation-sedation score [ Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes ]
  2. score of coughing [ Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes ]
    0=no coughing;1=intermittent coughing;2=continuous coughing

  3. time to response to verbal command [ Time Frame: from end of infusing anesthetics to response to verbal command,averagely 20 minutes ]
  4. time to extubation [ Time Frame: from end of infusing anesthetics to extubation,averagely 28 minutes ]
  5. blood pressure before and after extubation [ Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes ]
  6. blood glucose before and after aneurysm embolism [ Time Frame: immediately before inserting coil and after finishing inserting coil,an average of 1 hour ]
  7. blood lactate before and after aneurysm embolism [ Time Frame: immediately before inserting coil and after finishing inserting coil,,an average of 1 hour ]
  8. Mini-mental state examination score [ Time Frame: 24 hours after surgery ]


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

Inclusion Criteria:

  • patients undergoing cerebral aneurysm embolism under general anesthesia

Exclusion Criteria:

  • patients with bradycardia or atrioventricular heart block
  • patients with ASA(American Society of Anesthesiologists) status over 3
  • patients with body mass index(BMI)≥30kg/m2
  • patients with difficulty in communication
  • patients with ruptured aneurysm
  • patients suspected or proved to be pregnant

Information from the National Library of Medicine

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): NCT03355534


Contacts
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Contact: hailong dong, MD.PhD 86-29-84775337 hldong9@hotmail.com

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: zhihong lu    86-29-84775343    deerlu23@163.com   
Sponsors and Collaborators
Zhihong LU
Investigators
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Study Chair: Lize Xiong Fourth Military Medical University

Publications of Results:
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Responsible Party: Zhihong LU, clinical professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03355534     History of Changes
Other Study ID Numbers: XJH-A-2017-10-10
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhihong LU, Fourth Military Medical University:
dexmedetomidine
general anesthesia
cerebral aneurysm

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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