UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054614 |
|---|---|
| Receipt number | R000062401 |
| Scientific Title | A comparative study of the discontinuation rate of Intravenous patient-controlled analgesia used after posterior spinal fusion surgery with intraoperative ondansetron administration. A |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/06/09 17:07:39 |
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Basic information
Public title
A comparative study of the discontinuation rate of Intravenous patient-controlled analgesia used after posterior spinal fusion surgery with intraoperative ondansetron administration. 1
Acronym
A comparative study of the discontinuation rate of Intravenous patient-controlled analgesia used after posterior spinal fusion surgery with intraoperative ondansetron administration.
Scientific Title
A comparative study of the discontinuation rate of Intravenous patient-controlled analgesia used after posterior spinal fusion surgery with intraoperative ondansetron administration. A
Scientific Title:Acronym
A comparative study of the discontinuation rate of Intravenous patient-controlled analgesia used after posterior spinal fusion surgery with intraoperative ondansetron administration. B
Region
| Japan |
Condition
Condition
posterior spinal fusion surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare whether intraoperative administration of ondansetron affects the discontinuation rate of transvenous patient-controlled analgesia after posterior spinal fusion surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the discontinuation rate of transvenous patient-controlled analgesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anesthesia is administered by inhalation with sevoflurane and remifentanil. Fentanyl 9 mcg/kg and acetaminophen 15 mg/kg are administered as intraoperative analgesics. Transvenous patient-controlled analgesia is used for a total of 60 ml of fentanyl, saline, and 5 mg of droperidol to achieve 0.5 mcg/kg/h of fentanyl when used at 2 ml/h. During surgery, 4 mg of ondansetron and 1.25 mg of droperidol are administered.
Interventions/Control_2
Anesthesia is administered by inhalation with sevoflurane and remifentanil. Fentanyl 9 mcg/kg and acetaminophen 15 mg/kg are administered as intraoperative analgesics. Transvenous patient-controlled analgesia is used for a total of 60 ml of fentanyl, saline, and 5 mg of droperidol to achieve 0.5 mcg/kg/h of fentanyl when used at 2 ml/h. During surgery, 1.25 mg of droperidol are administered.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ASA-1 or 2 phyisical status patients undergoing posterior spinal fusion between 1 or 2 vertebrae from the date of approval by the Ethics Review Committee in 2024 and the date of the Institutional Director's approval until March 31, 2025.
Key exclusion criteria
1. Asthma 2. Long QT syndrome 3. Patients who did not give consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Soejima |
| Middle name | |
| Last name | Yuki |
Organization
Nagasaki rosai hospitsl
Division name
Anesthesiology
Zip code
857-0134
Address
2-12-5 Setogoe, Sasebo ciity, Nagasaki
TEL
0956-49-2191
shomu@nagasaki.johas.go.jp
Public contact
Name of contact person
| 1st name | Soejima |
| Middle name | |
| Last name | Yuki |
Organization
Nagasaki rosai hospital
Division name
Anesthesiology
Zip code
8570134
Address
2-12-5 Setogoe, Sasebo ciity, Nagasaki
TEL
09020869792
Homepage URL
yukisoejima08@gmail.com
Sponsor or person
Institute
Nagasaki rosai hospital, Anesthesiology, Yuki Soejima
Institute
Department
Personal name
Yuki Soejima
Funding Source
Organization
Nagasaki rosai hospital
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
Nagasaki rosai hospital
Address
2-12-5 Setogoe, Sasebo ciity, Nagasaki
Tel
0956492191
shomu@nagasaki.johas.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
0513
Org. issuing International ID_1
Nagasaki rosai hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 10 | 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
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 09 | Day |
Last modified on
| 2024 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062401
