UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021597 |
|---|---|
| Receipt number | R000024883 |
| Scientific Title | Effect of low dose ketamine for hypoesthesia of inferior alveolar nerve after sagittal split ramus osteotomy under general anesthesia |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2017/01/06 16:27:31 |
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Basic information
Public title
Effect of low dose ketamine for hypoesthesia of inferior alveolar nerve after sagittal split ramus osteotomy under general anesthesia
Acronym
Effect of ketamine for hypoesthesia of inferior alveolar nerve after sagittal split ramus osteotomy
Scientific Title
Effect of low dose ketamine for hypoesthesia of inferior alveolar nerve after sagittal split ramus osteotomy under general anesthesia
Scientific Title:Acronym
Effect of ketamine for hypoesthesia of inferior alveolar nerve after sagittal split ramus osteotomy
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Anesthesiology | Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inferior alveolar nerve(IAN) postoperative functional disturbance is the most common complication of the sagittal split ramus osteotomy(SSRO). The causes of Inferior alveolar nerve postoperative functional disturbance are nerve damage by inflammation, nerve compression by swelling and/or hematoma and swelling of mandibular canal. Some reports indicate that ketamine has anti-inflammatory effects and low dose ketamine improve pain, swelling and trismus after surgical extraction of third molars. The aim of the present study is to investigate the influence of ketamine on IAN postoperative functional disturbance after SSRO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of hypoesthesia of inferior alveolar nerve by von Frey stimulation and electrical stimulation at 1,3,7 days postoperatively
Key secondary outcomes
The degree of facial swelling by tape measure method and pain by visual analog scale at 1,3,7 days postoperatively
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration of 0.5mg/kg ketamine after induction of general anesthesia
Interventions/Control_2
Intravenous administration of saline after induction of general anesthesia
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with written informed consent who are scheduled for sagittal split rams osteotomy under general anesthesia and can understand the aim of the study
Key exclusion criteria
1.Patients who show hypoesthesia of inferior alveolar nerve before surgery
2.Patients who have an allergy to ketamine
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teppei Sago |
Organization
Kyushu Dental University
Division name
Department of dental anesthesiology
Zip code
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 JAPAN
TEL
093-582-1131
r07sagou@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teppei Sago |
Organization
Kyushu Dental University
Division name
Division of dental anesthesiology
Zip code
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 JAPAN
TEL
093-582-1131
Homepage URL
r07sagou@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 24 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024883
