UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009044 |
|---|---|
| Receipt number | R000010620 |
| Scientific Title | Evaluation of the efficacy of dexmedetomidine as an anesthetic and effects of spinal cord monitoring |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2013/04/02 16:36:45 |
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Basic information
Public title
Evaluation of the efficacy of dexmedetomidine as an anesthetic and effects of spinal cord monitoring
Acronym
Anesthesia with dexmedetomidine and effects on spinal cord monitoring
Scientific Title
Evaluation of the efficacy of dexmedetomidine as an anesthetic and effects of spinal cord monitoring
Scientific Title:Acronym
Anesthesia with dexmedetomidine and effects on spinal cord monitoring
Region
| Japan |
Condition
Condition
Spinal cord tumors, spinal disorders
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of dexmedetomidine as a general anesthetic. Spinal cord monitoring is monitoring of the spinal cord function to avoid nerve damage by surgical manipulations of the spine and spinal cord. The effects of dexmedetomidine on spinal cord monitoring are evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To evaluate the depth of anesthesia by BIS monitoring to validate the hypothesis that dexmedetomidine is effective as a general anesthetic.
Key secondary outcomes
To measure the amplitude and latency of the waveform obtained by spinal cord monitoring under general anesthesia using dexmedetomidine, and to evaluate its clinical advantages and safety.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The degree of sedation is evaluated on the basis of the value of the bispectral index calculated by BIS monitoring of brain waves, and the dose of dexmedetomidine is adjusted during surgery while monitoring the degree of surgical stress and hemodynamics. Dexmedetomidine is administered by continuous intravenous infusion. The amplitude and latency of the waveforms obtained by spinal cord monitoring are measured under general anesthesia with dexmedetomidine. Blood (1 ml) is sampled every hour to measure the blood dexmedetomidine concentration. The measurements are performed during the period of anesthetic management.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to undergo surgery of the spine or spinal cord at a Niigata university Medical and Dental hospital and need intraoperative spinal cord monitoring, those who are scheduled to be admitted to the ICU after surgery, those with histories of egg and soy bean allergy or convulsive attacks, those in whom the use of ketamine is difficult, those with GABA (A) receptor deletion, and those who consented to participation in the study after a sufficient explanation.
Key exclusion criteria
1. Patients who are or may be pregnant.
2. Patients undergoing blood purification therapy.
3. Patients with cardiovascular disorders.
4. Patients with reduced cardiac function.
5. Patients with a reduced circulating blood volume.
6. Patients with liver dysfunction.
7. Patients with kidney dysfunction.
8. Old patients (75 years or above).
9. Patients judged to be inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Ishii |
Organization
Niigata University
Division name
Medical and Dental Hospital, Anesthesiology
Zip code
Address
1-757 Asahi-machi, Chuo-ku, Niigata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Ishii |
Organization
Niigata University
Division name
Medical and Dental Hospital, Anesthesiology
Zip code
Address
1-757 Asahi-machi, Chuo-ku, Niigata
TEL
Homepage URL
Sponsor or person
Institute
Niigata University Medical and Dental Hospital, Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 02 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 02 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010620
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