Study of Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)for Treatment of Post Operative Nausea and Vomiting

NCT ID: NCT01984931

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Nausea; Vomiting

Keywords

post operative nausea and vomiting; Trimebutine Maleate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Trimebutine Maleate 300 mg Tab

A single dose of NEWBUTIN SR 300 mg Tab will be given orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

Group Type: EXPERIMENTAL

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)

Intervention Type: DRUG

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on'M' receptors. A single dose of NEWBUTIN SR 300 mg Tab orally will be given one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A

Anti-emetic medication protocol of Chungmu Hospital includes MACPERAN (Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A)thru IV twice in a day

Group Type: ACTIVE_COMPARATOR

Metoclopramide hydrochloride monohydrate

Intervention Type: DRUG

Interventions

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on'M' receptors. A single dose of NEWBUTIN SR 300 mg Tab orally will be given one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

Intervention Type: DRUG

Metoclopramide hydrochloride monohydrate

Intervention Type: DRUG

Other Intervention Names

•Antinime; •Cineprac; •Colixane B (Trimebutine and Bromazepam); •Colixane Prokin (Trimebutine and Mosapride); •Colixane; •Colonix B (Trimebutine and Bromazepam); •Colonix; •Colospasmyl; •Colperin; •Crobutin; •Debricol; •Debridat; •Débridat; •Eumotrix; •Ibuproct (Trimebutine and Ruscogenin); •Ibutin; •Libertrim; •Libertrim Pediátrico (pediatric); •Libertrim SDP (Trimebutine and Simeticone); •Libertrim SII (Trimebutine and Simeticone); •Muvett; •Polybutine; •Prescol; •Proctolog (Trimebutine and Ruscogenin); •Promebutin; •Ruscolog (Trimebutine and Ruscogenin); •Tribux; •Trimebutin; •Trimebutina Genfar; •Trimebutina La Santé; •Trimebutina; •Trimebutino Andromaco; •Trimedine; •Trimegam; •Trimet; •Altrip; •Apo-Trimebutine; •Biorgan B (Trimebutine and Bromazepam); •Biorgan; •Bumetin; •Butikinon; •Cerekinon; •Cerenamelin; •Colobutine; •Colypan; •Debretin; •Debricalm; •Debridat AP; •Debridat B (Trimebutine and Bromazepam); •Debridat Fort; •Debrum (Trimebutine and Medazepam); •Derispan; •Digerent; •Diway; •Dolpic; •Eumotil; •Eumotil-S (Trimebutine and Simeticone); •Eumotil-T (Trimebutine and Bromazepam); •Eutransil; •Fenatrop; •Garapepsin; •Gaspat; •Gismotal; •Liement; •Mebucolon; •Mebutit; •Miopropan; •Modulon; •Mustrick; •Muvett S (Trimebutine and Simeticone); •Newbutin SR; •Ni Wei Fu; •Pelkysil; •Pilemain; •Polibutin; •Recutin; •Rekelat; •Rui Jian; •Sakion; •Selumito; •Shuang Di; •Spabutine; •Spamoin; •Supeslone; •Sutent; •Tarabutine; •Tefmetin; •Tidomel; •Timotor; •Transacalm; •Tribudat Forte; •Tribudat; •Tributin; •Tricin; •Tridat; •Trienter; •Trim; •Trimebutin Maleate Taiyo; •Trimebutina Angenerico; •Trimebutina Colmed; •Trimebutina maleato; •Trimebutina MK; •Trimébutine Actavis; •Trimébutine Almus; •Trimébutine ALS; •Trimébutine Arrow; •Trimébutine Biogaran; •Trimébutine CristerS; •Trimébutine EG; •Trimébutine Evolugen; •Trimébutine Isomed; •Trimébutine maléate RPG; •Trimébutine Mylan; •Trimébutine Pfizer; •Trimébutine Qualimed; •Trimébutine Ranbaxy; •Trimébutine Ratio; •Trimébutine Ratiopharm; •Trimébutine Sandoz; •Trimébutine Teva; •Trimébutine Zentiva; •Trimébutine Zydus; •Trimebutino Maleato; •Trimedat; •Trishi; •VeM; •Yuan Sheng Li Wei

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea United Pharm. Inc.

INDUSTRY

Sponsor Role: collaborator

CM Chungmu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang-Hoon Lhee

Director of CM Chungmu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Alan B Tabar, MD

Role: PRINCIPAL_INVESTIGATOR

International Education Center of Shoulder, Elbow Surgery: Chungmu Hospital

Locations

Chungmu General Hopsital

Seoul, Yeongdeungpo-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Hoon Lhee, MD, PhD

Role: CONTACT

Phone: +82 (2) 2068/4525

Email: cmirb@naver.com

Facility Contacts

Sang Hoon Lhee, MD, Phd

Role: primary

Other Identifiers

CMH-2013-02

Identifier Type: -

Identifier Source: org_study_id