UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052211 |
|---|---|
| Receipt number | R000059580 |
| Scientific Title | Prospective clinical study on prophylactic efficacy of ondansetron against post-operative nausea and vomiting in children undergoing laparoscopic surgery for inguinal hernia. |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2023/09/14 18:12:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study on prophylactic efficacy of ondansetron against post-operative nausea and vomiting in children undergoing laparoscopic surgery for inguinal hernia.
Acronym
Clinical study on prophylactic efficacy of ondansetron against post-operative nausea and vomiting in children undergoing laparoscopic surgery for inguinal hernia.
Scientific Title
Prospective clinical study on prophylactic efficacy of ondansetron against post-operative nausea and vomiting in children undergoing laparoscopic surgery for inguinal hernia.
Scientific Title:Acronym
Prospective clinical study on prophylactic efficacy of ondansetron against post-operative nausea and vomiting in children undergoing laparoscopic surgery for inguinal hernia.
Region
| Japan |
Condition
Condition
Pediatric inguinal hernia
Classification by specialty
| Surgery in general | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate prophylactic efficacy of ondansetron against post-operative nausea and vomiting in children undergoing laparoscopic surgery for inguinal hernia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-operative nausea and vomiting (within 24 hours after surgery)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Prophylactic administration of ondansetron (peri-operative period)
Interventions/Control_2
Placebo
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children undergoing elective laparoscopic surgery for inguinal hernia (under 15 years old, ASA-PS from 1 to 2) in Saitama Municipal Hospital.
2. Patients (and/or their guardian) who provided an explanation of the study plan before surgery, fully understood the objectives of the study, and
obtained written consent.
Key exclusion criteria
1. Patients who are allergic to any of the drugs used in this study.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Jyunya |
| Middle name | |
| Last name | Oshida |
Organization
Saitama Municipal Hospital
Division name
Department of Anesthesiology
Zip code
3368522
Address
2460 Mimuro Midori-ku Saitama-shi Saitama
TEL
0488734111
oswillkommen@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Municipal Hospital
Division name
Department of critical care medicine
Zip code
3368522
Address
2460 Mimuro Midori-ku Saitama-shi Saitama
TEL
0488734111
Homepage URL
gomachan4761@energy.ocn.ne.jp
Sponsor or person
Institute
Saitama Municipal Hospital
Institute
Department
Personal name
Jyunya Oshida
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Municipal Hospital
Address
2460 Mimuro Midori-ku Saitama-shi Saitama
Tel
0488734111
hsp-jimukyoku-shomu@city.saitama.lg.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
| 2023 | Year | 09 | Month | 15 | 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
| 2022 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059580
