Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076099
Recruitment Status : Unknown
Verified March 2017 by Nan Jiang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Nan Jiang, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Dexmedetomidine Other: normal saline Not Applicable

Detailed Description:
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization. The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number. Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline. Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two parallel groups
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: this investigation is a triple mask study. The patiens, the care providers and Outcome Assessor will not allowed to know the grouping information.
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
Drug: Dexmedetomidine
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
Other Name: DEX

Placebo Comparator: Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
Other: normal saline
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
Other Name: NS




Primary Outcome Measures :
  1. urapidil consumption [ Time Frame: the end of the 6th hour after tracheal extubation ]
    urapidil consumption was recorded by nurses every hour


Secondary Outcome Measures :
  1. urapidil consumption on POD1 [ Time Frame: the total consumption of urapidil on post-operative day 1. ]
    urapidil consumption was recorded by nurses every hour

  2. urapidil consumption on POD2 [ Time Frame: the total consumption of urapidil on post-operative day 2. ]
    urapidil consumption was recorded by nurses every hour

  3. Visual Analogue score [ Time Frame: the end of the 6th hour after tracheal extubation ]
    visual analogue score was measured by visual analogue scale

  4. Visual Analogue score at 24th hour [ Time Frame: the end of the 24th hour after tracheal extubation ]
    visual analogue score was measured by visual analogue scale

  5. Visual Analogue score at 48th hour [ Time Frame: the end of the 48th hour after tracheal extubation ]
    visual analogue score was measured by visual analogue scale

  6. Quality of Recovery Score [ Time Frame: the end of the 6th hour after tracheal extubation ]
    Quality of Recovery Score was measured by a 15-item quality of recovery scale

  7. Quality of Recovery Score at 24th hour [ Time Frame: the end of the 24th hour after tracheal extubation ]
    Quality of Recovery Score was measured by a 15-item quality of recovery scale

  8. Quality of Recovery Score at 48th hour [ Time Frame: the end of the 48th hour after tracheal extubation ]
    Quality of Recovery Score was measured by a 15-item quality of recovery scale

  9. Analgesics consumption [ Time Frame: the end of the 6th hour after tracheal extubation ]
    Analgesics consumption was recorded by nurse every hour

  10. Analgesics consumption on POD1 [ Time Frame: the total consumption of urapidil on post-operative day 1. ]
    Analgesics consumption was recorded by nurse every hour

  11. Analgesics consumption on POD2 [ Time Frame: the total consumption of urapidil on post-operative day 2. ]
    Analgesics consumption was recorded by nurse every hour

  12. Bradycardia [ Time Frame: the end of the 6th hour after tracheal extubation ]
    a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse

  13. Bradycardia at 24th hour [ Time Frame: the end of the 24th hour after tracheal extubation ]
    a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse

  14. Bradycardia at 48th hour [ Time Frame: the end of the 48th hour after tracheal extubation ]
    a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse

  15. PONV [ Time Frame: the end of the 6th hour after tracheal extubation ]
    post-operative nausea and vomiting (PONV) was recorded by nurse

  16. PONV at 24th hour [ Time Frame: the end of the 24th hour after tracheal extubation ]
    post-operative nausea and vomiting (PONV) was recorded by nurse

  17. PONV at 48th hour [ Time Frame: the end of the 48th hour after tracheal extubation ]
    post-operative nausea and vomiting (PONV) was recorded by nurse



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.

Exclusion Criteria:

  • abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.

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): NCT03076099


Contacts
Layout table for location contacts
Contact: Nan Jiang, PhD 86 20 28823350 NJiang_sysu@126.com

Locations
Layout table for location information
China, Guangdong
the First Affiliated Hospital of Sun Yetsen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yi Liu, Master    +86 13632391455    liuyisysu@126.com   
Contact: Nan Jiang, professor    +86 20 28823350    NJiang_sysu@126.com   
Sponsors and Collaborators
Nan Jiang

Layout table for additonal information
Responsible Party: Nan Jiang, associate professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03076099     History of Changes
Other Study ID Numbers: NJiang2016-001
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the IPD will not be shared with others, since following investigations based on this trial is about to start.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nan Jiang, First Affiliated Hospital, Sun Yat-Sen University:
Dexmedetomidine
brain arteriovenous malformation
embolization
post-operative hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular 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