Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations

Tracking Information
First Submitted Date ICMJE	July 8, 2012
First Posted Date ICMJE	July 11, 2012
Last Update Posted Date	May 8, 2015
Study Start Date ICMJE	December 2011
Actual Primary Completion Date	February 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 10, 2012)	incidence and severity of nausea and vomiting [ Time Frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01637545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 10, 2012)	patient satisfaction with the effect [ Time Frame: at 24 h after surgery ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations
Official Title ICMJE	Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations
Brief Summary	Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.
Detailed Description	Participants 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups; Randomization G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room G3(n=33) - No medication but regular antiemetics i.v. if the patient wants; The primary endpoint the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h; The secondary endpoints the severity of nausea, need for rescue medication patient satisfaction with efficacy
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
Condition ICMJE	Facial Bones Fracture
Intervention ICMJE	Drug: Ramosetron; G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room G3 - No medication but regular antiemetics injection if the patient want; Other Name: Nasea®
Study Arms	Active Comparator: Preop. ramosetron 0.3mg i.v. G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery Intervention: Drug: Ramosetron; Active Comparator: Postop. ramosetron 0.3mg i.v. G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room Intervention: Drug: Ramosetron; Active Comparator: No Ramosetron G3 - No medication but regular antiemetics injection if the patient wants Intervention: Drug: Ramosetron
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 10, 2015)	49
Original Estimated Enrollment ICMJE; (submitted: July 10, 2012)	99
Actual Study Completion Date	February 2015
Actual Primary Completion Date	February 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patient who sign informed consent form for the study; patient who are considered as surgical candidates with facial bones fracture Exclusion Criteria: Patient who have had nausea/vomiting episodes
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01637545
Other Study ID Numbers ICMJE	B-1107-131-007; L-2011-329-1 ( Other Grant/Funding Number: Astellas Pharm. Co. )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Chan-Yeong Heo, Seoul National University Hospital
Study Sponsor ICMJE	Seoul National University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Chanyeong Heo, Ph.D. Seoul National University Bundang Hospital
PRS Account	Seoul National University Hospital
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP