UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008898 |
|---|---|
| Receipt number | R000010255 |
| Scientific Title | A comparison of fosaprepitant and droperidol for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: a randomized double-blinded study |
| Date of disclosure of the study information | 2012/09/12 |
| Last modified on | 2015/09/27 10:37:42 |
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Basic information
Public title
A comparison of fosaprepitant and droperidol for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: a randomized double-blinded study
Acronym
Intraoperative Fosaprepitant for Craniotomy Trial (IFOSAC trial)
Scientific Title
A comparison of fosaprepitant and droperidol for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: a randomized double-blinded study
Scientific Title:Acronym
Intraoperative Fosaprepitant for Craniotomy Trial (IFOSAC trial)
Region
| Japan |
Condition
Condition
craniotomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fosaprepitant is highly effective for prevention of nausea and vomiting and is used in Japan only in chemotherapy. In this randomized double-blinded study, we aimed to clarify the efficacy of fosaprepitant for prevention of postoperative nausea and vomiting (PONV) in craniotomy, using droperidol as a control drug.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative accumulative incidence of PONV within 72 hours after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved 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
Fosaprepitant group (group F) : drug 1 (= fosaprepitant 150mg + saline 100ml) and dexamethason 10mg is intravenously administered after induction of anesthesia and drug 2 (saline 2ml) is intravenously administered 30 minutes before end of surgery.
Interventions/Control_2
Droperidol group (group D) : drug 1 (= saline 100ml) and dexamethason 10mg is intravenously administered after induction of anesthesia and drug 2 (droperidol 0.625mg/0.25ml + saline1.75ml) is intravenously administered 30 minutes before end of 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 from 20 years old to 80 years old undergoing craniotomy
Key exclusion criteria
1. high risk patient (ASA risk 4 and above)
2. patient with low level of consciousness (Japan Coma Scale 2 and above)
Patient with preoperative lowered consciousness is excluded before registration and patient with postoperative lowered consciousness is excluded when it is detected. Patient who exits from operating room with tracheal intubation is also excluded from analysis.
3. patient with nausea or vomiting before surgery
4. antiemetic-taken patient within 24 hours before surgery
5. patient with motions disease
6. patient with highly impaired liver function and renal function
7. patient with morbid obesity (BMI more than 35)
8. patient with allergy to fosaprepitant, aprepitant, droperidol, dexamethasone, propofol, or rocronium
9. patient with cognitive dysfunction
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawaguchi |
Organization
Nara medical university
Division name
Department of anesthesiology
Zip code
Address
840, Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
drjkawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Atsuta |
Organization
Nara medical university
Division name
Department of anesthesiology
Zip code
Address
840, Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
atsutajun@gmail.com
Sponsor or person
Institute
Department of anesthesiology, Nara medical university
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
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
| 2012 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 11 | Day |
Last modified on
| 2015 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010255
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