UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016644 |
|---|---|
| Receipt number | R000019312 |
| Scientific Title | Non-inferiority trial of cardiovascular dynamics of lidocaine with adrenaline injection under general anesthesia between antipsychotics patients and control patients |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2022/03/03 10:03:24 |
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Basic information
Public title
Non-inferiority trial of cardiovascular dynamics of lidocaine with adrenaline injection under general anesthesia between antipsychotics patients and control patients
Acronym
Cardiovascular dynamics of lidocaine with adrenaline injection to antipsychotics patients
Scientific Title
Non-inferiority trial of cardiovascular dynamics of lidocaine with adrenaline injection under general anesthesia between antipsychotics patients and control patients
Scientific Title:Acronym
Cardiovascular dynamics of lidocaine with adrenaline injection to antipsychotics patients
Region
| Japan |
Condition
Condition
patients taking antipsychotics
Classification by specialty
| Psychiatry | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This non-inferiority trial is comparison of cardiovascular dynamics between antipsychotics patients and control patients under general anesthesia.
These patients are measured of vital sign after lidocaine with adrenaline injection
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Incidence of blood pressure decrease over 31 mmHg until 10 minutes after injection
2)Adverse event until 24 hours after injection
Key secondary outcomes
Abnormity of vital sign after injection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)No premedication
2)Patients administer GA by TIVA (air, oxygen, propofol and remifentanil)
3)Take base line measurements if vital sign stable
4)One point eight ml lidocaine with adrenaline injection to oral mucosa during 30 seconds
5)Measurement of blood pressure at 0,4,10 minutes after injection
6)Give pressor drugs when systolic pressure under 70 mmHg, and time drug name and dose be recorded
7)Dental procedure start after ten minutes
8)Measurement of blood pressure, heart rate and SpO2 every 5 minutes after injection
Interventions/Control_2
1)No premedication
2)Patients administer GA by TIVA (air, oxygen, propofol and remifentanil)
3)Take base line measurements if vital sign stable
4)One point eight ml lidocaine with adrenaline injection to oral mucosa during 30 seconds
5)Measurement of blood pressure at 0,4,10 minutes after injection
6)Give pressor drugs when systolic pressure under 70 mmHg, and time drug name and dose be recorded
7)Dental procedure start after ten minutes
8)Measurement of blood pressure, heart rate and SpO2 every 5 minutes after injection
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
dental patients under general anesthesia and dental patients he or she taking antipsychotics under general anesthesia
Key exclusion criteria
1)ASA over 3
2)Taking circulation drugs
3)Taking tricyclic antidepressants
4)History of local anesthetics allergy
5)History of Hypertension, Arteriosclerosis, heart failure, hyperthyroidism, diabetes
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | katsuhisa |
| Middle name | |
| Last name | sunada |
Organization
Nippon Dental University
Division name
dental anesthesiology
Zip code
102-8157
Address
Fujimi
TEL
03-3261-6064
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | katsuhisa |
| Middle name | |
| Last name | sunada |
Organization
Nippon Dental University
Division name
dental anesthesiology
Zip code
102-8157
Address
Fujimi
TEL
03-3261-6064
Homepage URL
katsu.sunada@nifty.com
Sponsor or person
Institute
the japanese dental society of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
japanese association for dental science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of JDSA
Address
1-43-9 Komagome Toshima Tokyo Japan
Tel
03-3947-8891
gakkai12@kokuhoken.or.jp
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
日本歯科大学生命歯学部、昭和大学歯学部、東京歯科大学、東京医科歯科大学歯学部（以上東京都）、神戸市立医療センター西市民病院（兵庫県）、徳島大学歯学部（徳島県）、岩手医科大学歯学部（岩手県）、鹿児島大学歯学部（鹿児島県）、福岡歯科大学（福岡県）、大阪大学歯学部（大阪府）、日本歯科大学新潟生命歯学部（新潟県）、神奈川歯科大学（神奈川県）、岡山大学歯学部（岡山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://meridian.allenpress.com/anesthesia-progress/article/68/3/141/471169/Hemodynamic-Impact-of-Dr
Publication of results
Published
Result
URL related to results and publications
https://meridian.allenpress.com/anesthesia-progress/article/68/3/141/471169/Hemodynamic-Impact-of-Dr
Number of participants that the trial has enrolled
30
Results
No statistically significant changes were observed in the SBP, DBP, HR, or SpO2 for the 10 minute period after the administration of epinephrine
containing lidocaine. No abnormalities in the
hemodynamic parameters were noted over the 1 hour period following the local anesthetic
injection.
Results date posted
| 2022 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Regularly used typical and/or atypical
antipsychotics for more than 3 months and were
scheduled for restorative dental procedures and/or extractions under general anesthesia at
Nippon Dental University Hospital.
Participant flow
Informed consent was obtained from all
individual participants or legal guardians
included in the study.
Adverse events
None
Outcome measures
systolic blood pressure, diastolic blood pressure, heart rate, oxygen saturation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019312
