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

Seoul National University

Status and phase: Terminated; Phase 4

Conditions: Facial Bones Fracture

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01637545

B-1107-131-007

L-2011-329-1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 49 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

49 participants in 3 patient groups

Preop. ramosetron 0.3mg i.v.

Active Comparator group

Description:

G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery

Treatment:

Drug: Ramosetron

Postop. ramosetron 0.3mg i.v.

Active Comparator group

Description:

G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room

Treatment:

Drug: Ramosetron

No Ramosetron

Active Comparator group

Description:

G3 - No medication but regular antiemetics injection if the patient wants

Treatment:

Drug: Ramosetron