Clinical trial NCT01984931: Study of Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)for Treatment of Post Operative Nausea and Vomiting
Official title: Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) as a Prophylactic Anti-emetic Drug for Patients Who Underwent Arthroscopic Rotator Cuff Repair: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nausea
Vomiting
Keywords: post operative nausea and vomiting
Trimebutine Maleate
Lead sponsor: CM Chungmu Hospital
Sponsor class: OTHER
Collaborators: name: Korea United Pharm. Inc.
First posted: 2013-11-15
Enrollment: 45
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.

Detailed description: The patients will be divided in two groups using a computer generated randomization software. The first will be the MACPERAN group (controlled) and the other will be the NEWBUTIN group (variable). The controlled group will be treated with post-operative regimen in accordance with the standard protocol of the Chungmu Hospital, MACPERAN(Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A) thru IV twice in a day while the variable group will be given a single dose of NEWBUTIN SR 300 mg Tab orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

A clinical research coordinator will monitor the patient until 48 hours post-operative. First time frame will be from 0-2 hours once patient is transferred to the ward followed by 2 hours to 24 hours and 24-48 hours post ward transfer. All patients will be assessed using the simplified risk score of Apfel et al. to determine who have the risk factors for PONV. The episodes of nausea and vomiting will be recorded taking note of its intensity and frequency on the said three time frames. Nausea is defined as a subjectively unpleasant sensation associated with an awareness of the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents through the mouth. As retching is similar to vomiting in all aspects, except for the expulsion of gastric contents, it was considered as vomiting. The efficacy of anti-emetic medication (NEWBUTIN 300 mg/tab) will be assessed by monitoring the frequency and severity of nausea, vomiting, and PONV (which was regarded as the primary outcome). The severity of nausea will be graded on a four-point scale, where 0= no nausea, 1= mild nausea, 2= moderate nausea, and 3= severe nausea.Then the frequency will be assessed by monitoring how often the patient experienced these episodes (nausea and vomiting)during the said time frames.

Eligibility criteria: Inclusion Criteria:

* post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru MRI

Exclusion Criteria:

* above 70 years old
* massive rotator cuff tear

Primary outcomes:
measure: Severity of nausea after taking Trimebutine Maleate as a prophylactic medication
timeFrame: 0-48 hours post rotator cuff repair
Secondary outcomes:
measure: Frequency of PONV after taking Trimebutine Maleate as a prophylactic medication
timeFrame: 0-48 hours post rotator cuff repair
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chungmu General Hopsital
state: Yeongdeungpo-gu
Study officials:
affiliation: International Education Center of Shoulder, Elbow Surgery: Chungmu Hospital
name: Paolo Alan B Tabar, MD
role: PRINCIPAL_INVESTIGATOR
References: