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

This study is currently recruiting participants.
Verified April 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Chan-Yeong Heo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01637545
First received: July 8, 2012
Last updated: April 4, 2014
Last verified: April 2014

July 8, 2012
April 4, 2014
December 2011
August 2014   (final data collection date for primary outcome measure)
incidence and severity of nausea and vomiting [ Time Frame: for 24 h after surgery at 0-6h, 6-12 h and 12-24 h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01637545 on ClinicalTrials.gov Archive Site
patient satisfaction with the effect [ Time Frame: at 24 h after surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations
Phase 4 Study of Nasea(R)/Ramosetron Inj.as Anti-emetics in the Patients Undergoing Facial Bone Fracture Operations

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.

  1. Participants

    • 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
  2. 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
  3. The primary endpoint

    • the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
  4. The secondary endpoints

    • the severity of nausea, need for rescue medication
    • patient satisfaction with efficacy
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Facial Bones Fracture
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®
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
99
October 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Chanyeong Heo, Ph.D. 82-31-787-7222 lionheo@snu.ac.kr
Contact: Jihoon Kim, Master 82-31-787-7229 89021@snubh.org
Korea, Republic of
 
NCT01637545
B-1107-131-007, L-2011-329-1
No
Chan-Yeong Heo, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Chanyeong Heo, Ph.D. Seoul National University Bundang Hospital
Seoul National University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP