UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048300 |
|---|---|
| Receipt number | R000055041 |
| Scientific Title | Comparison of ondansetron and droperidol on prevention of postoperative nausea and vomiting in patients receiving intravenous patient-controlled analgesia after surgery with general anesthesia. |
| Date of disclosure of the study information | 2022/07/06 |
| Last modified on | 2023/01/04 12:15:31 |
* 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
Comparison of ondansetron and droperidol on prevention of postoperative nausea and vomiting in patients receiving intravenous patient-controlled analgesia after surgery with general anesthesia.
Acronym
Comparison of ondansetron and droperidol on prevention of postoperative nausea and vomiting with iv-PCA.
Scientific Title
Comparison of ondansetron and droperidol on prevention of postoperative nausea and vomiting in patients receiving intravenous patient-controlled analgesia after surgery with general anesthesia.
Scientific Title:Acronym
Comparison of ondansetron and droperidol on prevention of postoperative nausea and vomiting with iv-PCA.
Region
| Japan |
Condition
Condition
Postoperative nausea and vomiting after surgery with general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare conventional drug, droperidol and ondansetron as antiemetics for intravenous patient-controlled analgesia used for postoperative analgesia of general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of nausea and vomiting for 24 hours after surgery of the droperidol group and ondansetron group.
Key secondary outcomes
Non-inferiority of ondansetron to droperidol. Presence or absence of side effects (headache, dizziness, extrapyramidal symptoms, oversedation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
We fill 8 mg of ondansetron as an antiemetic and 10 ml of fentanyl as an analgesic in an iv-PCA pump and administer them continuously for 24 hours after surgery.
Interventions/Control_2
We fill 2.5mg of droperidol as an antiemetic and 10 ml of fentanyl as an analgesic in an iv-PCA pump and administer them continuously for 24 hours after 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective surgery under general anesthesia and receiving intravenous patient controlled analgesia after surgery.
Key exclusion criteria
Those with hypersensitivity to ondansetron and droperidol, those with severe deterioration of cardiopulmonary / hepato-renal function, those who cannot properly answer postoperative questions.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe city medical center general hospital
Division name
department of anesthesiology
Zip code
6500047
Address
Kobe city Chuouku Minatojimaminamichou2-1-1
TEL
0783024321
cantateveritas@kcho.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe city medical center general hospital
Division name
department of anesthesiology
Zip code
6500047
Address
Kobe city Chuouku Minatojimaminamichou2-1-1
TEL
0783024321
Homepage URL
cantateveritas@kcho.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe city medical center general hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city medical center general hospital
Address
Kobe city Chuouku Minatojimaminamichou2-1-1
Tel
0783024321
cantateveritas@kcho.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
| 2022 | Year | 07 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055041
