- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013012
Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
February 2, 2012 updated by: Yonsei University
The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females
- Ages 18 to 65 years old
Exclusion Criteria:
- Patients who is taking steroid or who had been treated for the gastrointestinal disease
- Patients who have troubles with the kidney or liver
- Patients transferring to the ICU after the surgery
- overfat patients
- Patients who had taken antiemetics within 24 hours before the surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
Group A : saline 1 ml + ramosetron 6μg/kg
|
Group A : saline 1 ml, ramosetron 6μg/kg
|
Experimental: Group B
Group B : dexamethasone 4 mg + ramosetron 6μg/kg
|
Group B : dexamethasone 4 mg, ramosetron 6μg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of postoperative nausea and vomiting(PONV)
Time Frame: After spinal surgery
|
incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients
|
After spinal surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
November 12, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (Estimate)
November 13, 2009
Study Record Updates
Last Update Posted (Estimate)
February 3, 2012
Last Update Submitted That Met QC Criteria
February 2, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Serotonin Agents
- Serotonin Antagonists
- Dexamethasone
- Ramosetron
Other Study ID Numbers
- 4-2007-0388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nausea
-
University of North Carolina, Chapel HillNational Institute of Dental and Craniofacial Research (NIDCR)CompletedPost-operative Nausea | Post-operative Vomiting | Nausea PersistentUnited States
-
Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
Lancaster General HospitalCompletedBariatric Surgery Candidate | Nausea, PostoperativeUnited States
-
Hoffmann-La RocheCompletedPost-Operative Nausea and VomitingUnited States
-
Cairo UniversityUnknownPost Operative Nausea and VomitingEgypt
-
Yonsei UniversityCompletedPost Operative Nausea and VomitingKorea, Republic of
-
AccentureCompletedPost-Operative Nausea and Vomiting (PONV)Australia
-
Blokhin's Russian Cancer Research CenterRUSSCO/RakFondUnknownChemotherapy-induced Nausea and Vomiting | Nausea | Vomiting | Emesis | Nausea Post ChemotherapyRussian Federation
Clinical Trials on ramosetron with saline
-
Pusan National University Yangsan HospitalKorean Medicine Hospital of Pusan National University; Korea Institute of Oriental...CompletedColorectal Neoplasms | Postoperative Nausea and VomitingKorea, Republic of
-
Yonsei UniversityCompletedPostoperative Nausea and VomitingKorea, Republic of
-
Seoul National University Bundang HospitalUnknownNausea | Vomiting | Laparoscopic CholecystectomyKorea, Republic of
-
Chonnam National University HospitalCompletedColon CancerKorea, Republic of
-
Ajman UniversityUniversitat Internacional de CatalunyaActive, not recruitingPost Operative Pain | Endodontically Treated TeethUnited Arab Emirates
-
Slagelse HospitalZealand University Hospital; Copenhagen University Hospital at Herlev; Holbaek... and other collaboratorsNot yet recruitingAsthma in Children | Bronchiolitis | Respiratory Disease | Acute Respiratory Infection | Viral Infection
-
Vanderbilt University Medical CenterCompleted
-
The Hospital for Sick ChildrenCompleted
-
Uppsala County Council, SwedenRecruitingNecrotizing Enterocolitis | Time to Full Enteral NutritionSweden
-
The Catholic University of KoreaUnknownHematologic MalignanciesKorea, Republic of