UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046776 |
|---|---|
| Receipt number | R000053359 |
| Scientific Title | Antiemetic prophylaxis from postoperative nausea and vomiting in orthognathic surgery: a randomized, double-blind comparison of granisetron |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/08/05 09:38:35 |
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Basic information
Public title
Antiemetic prophylaxis from postoperative nausea and vomiting in orthognathic surgery: a randomized, double-blind comparison of granisetron
Acronym
Antiemetic prophylaxis from postoperative nausea and vomiting in orthognathic surgery: a randomized, double-blind comparison of granisetron
Scientific Title
Antiemetic prophylaxis from postoperative nausea and vomiting in orthognathic surgery: a randomized, double-blind comparison of granisetron
Scientific Title:Acronym
Antiemetic prophylaxis from postoperative nausea and vomiting in orthognathic surgery: a randomized, double-blind comparison of granisetron
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of this double-blind randomized study is to evaluate the antiemetic efficacy of three 5-hydroxxytryptamin type 3 (HT3) antagonist, granisetron in terms of the incidence and intensity of postoperative nausea and vomiting (PONV) in patients undergoing orthognathic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the incidence rate and intensity of PONV and number of rescue antiemetics (metoclopramide) at four time points for the 24-h study period after orthognathic surgery
Key secondary outcomes
Nausea intensity is measured using a numeric rating scale.
To evaluate safely by incidence of adverse effects as drug-induced liver injury and allergy or anaphylaxis at four time points (0-2h, 2-6h, 6-12h, and 12-24h interval).
Rescue drug, metoclopramide is given 10mg intravenously.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group of patients receive an intravenous bolus of 1mg granisetron (KYTRIL) at the end of orthognathic surgery.
To evaluate the incidence rate and intensity of PONV and number of rescue at four time points until 24 hours after orthognathic surgery.
Interventions/Control_2
Control group receive an intravenous bolus of 1mL normal saline at the end of orthognathic surgery.
To evaluate the incidence rate and intensity of PONV and number of rescue at four time points until 24 hours after orthognathic surgery.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Jaw deformity patients that are eligible for orthognathic surgery at Kyoto jaw deformity center.
They are American Society of Anesthesiology (ASA) 1 or 2 status.
A research associate described the research to each subject and obtained written consent or assent with parental permission.
Key exclusion criteria
Patients without consent of the research.
Patients with allergy with granisetron.
Target sample size
244
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Mori |
Organization
Rakuwakai Otowa Hospital
Division name
Kyoto jaw deformity center
Zip code
607-8062
Address
2, Orowa chinji-cho, Yamashina-ku, Kyoto city, Kyoto prefecture, 607-8062, Japan
TEL
075-593-4111
mori-hiroki@rakuwa.or.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Mori |
Organization
Rakuwakai Otowa Hospital
Division name
Kyoto jaw deformity center
Zip code
607-8062
Address
2, Orowa chinji-cho, Yamashina-ku, Kyoto city, Kyoto prefecture, 607-8062, Japan
TEL
075-593-4111
Homepage URL
mori-hiroki@rakuwa.or.jp
Sponsor or person
Institute
Kyoto jaw deformity center, Rakuwakai Otowa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Rakuwakai Clinical Research Center
Address
51-4, Otowa Hachinotsubo, Yamashina-ku, Kyoto city
Tel
075-593-4117
kotera-katsuaki@rakuwa.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
洛和会音羽病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053359
