UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008898
Receipt No. 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

* 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 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
Email 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
Email atsutajun@gmail.com

Sponsor
Institute Department of anesthesiology, Nara medical university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010255

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.