UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019712 |
|---|---|
| Receipt number | R000022767 |
| Scientific Title | The preliminary study for a change in circulation of patients with oral antipsychotic drugs administrated the lidocaine with adrenaline under general anesthesia |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2020/12/09 21:15:18 |
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Basic information
Public title
The preliminary study for a change in circulation of patients with oral antipsychotic drugs administrated the lidocaine with adrenaline under general anesthesia
Acronym
The preliminary study for a change in circulation of patients with oral antipsychotic drugs
Scientific Title
The preliminary study for a change in circulation of patients with oral antipsychotic drugs administrated the lidocaine with adrenaline under general anesthesia
Scientific Title:Acronym
The preliminary study for a change in circulation of patients with oral antipsychotic drugs
Region
| Japan |
Condition
Condition
Patients with oral antipsychotic drug
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the change in circulation of patients with oral antipsychotic drugs receiving lidocaine with adrenaline under general anesthesia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The systolic blood pressure and diastolic blood pressure of 4 and 10 minutes after the administration of the local anesthesia with adrenaline
Key secondary outcomes
The adverse events after 24 hours
The heart rate and percutaneous arterial oxygen saturation after the administration of the dental local anesthesia with adrenaline
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with antipsychotic drugs for 3 months who have the plan of the use of lidocaine with adrenaline under a general anesthesia in the special care dentistry center or central operation rooms of Okayama university hospital
Key exclusion criteria
1) ASA(American Society of Anesthesiologists)3 degrees or more
2) 15 years old or younger and 65 years old or older
3) Patients receiving inotropes
4) Patients receiving tricyclic antidepressants
5) Patients with allergy for dental local anesthesia
6) Patients with hypertension, arteriosclerosis, heart failure, hyperthyroidism, diabetes and a history of vasospasm
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Miyawaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6721
miyawaki@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Miyawaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
700-8525
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6721
Homepage URL
miyawaki@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6503
mae6605@adm.okayama-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
Unpublised
Publication of results
Unpublished
Result
URL related to results and publications
unpublised
Number of participants that the trial has enrolled
11
Results
The systolic blood pressure (mean (S.D)) at pre-administration of 2% lidocaine with adrenaline, 4min, and 10 min after administration of it were 111.3(21.4), 107.0(18.8), and 111.7(19.6) mmHg respectively, and there was no significant difference. Similarly, the diastolic blood pressure at pre-administration, 4min, and 10 min after administration were 56.6(18.0), 52.3(16.2), 53.0(15.5) mmHg respectively, and the diastolic blood pressure at 4min after administration was significantly lower than control.
Results date posted
| 2020 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sex (male:10, female:1), age:24.2(8.7) years, height: 164.7(12.5) cm, body weight: 70.2(19.3) kg
Participant flow
General anesthesia was performed on the study subjects, then lidocaine with adrenaline was injected into the oral cavity, and their blood pressure was observed. After observation, the subjects underwent scheduled dental treatments.
Adverse events
None
Outcome measures
The systolic blood pressure and diastolic blood pressure of 4 and 10 minutes after the administration of the local anesthesia with adrenaline
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study design: Longitudinal study
The way for subscription: The all patients satisfied selection criteria of this study for November in 2015 to March in 2017
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022767
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