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Dopamine Antagonist
Amisulpride for Postoperative Nausea and Vomiting
Phase 2 & 3
Recruiting
Led By Kumar Belani, MD
Research Sponsored by Acacia Pharma Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patients aged from full-term birth to 17 years of age
Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of Endotracheal tube (ETT) or Laryngeal mask airway (LMA)
Must not have
Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tested the effectiveness of amisulpride in preventing nausea and vomiting after surgery in children.
Who is the study for?
This trial is for children from birth to 17 years old who are having non-emergency surgeries like eye surgery, adenotonsillectomy, or otoplasty. They must be healthy enough for anesthesia (ASA I-III) and girls able to have babies must use strong contraception.
What is being tested?
The study tests Amisulpride Injection vs Dexamethasone in preventing sickness after surgery in kids. It's a randomized, double-blind trial meaning neither the doctors nor patients know who gets which treatment.
What are the potential side effects?
Possible side effects of Amisulpride include restlessness, increased heart rate, low blood pressure, and potential hormonal changes. Dexamethasone may cause irritation at injection site, mood swings, increased appetite and immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 17 years old or younger.
Select...
I am having a planned surgery, likely on my eyes, adenoids, tonsils, or ears, not using only propofol, lasting over 30 minutes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for a transplant or brain surgery.
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I will need a feeding tube after my surgery.
Select...
I am expected to receive corticosteroids for reasons other than preventing nausea.
Select...
I have a long-term problem with dizziness or balance.
Select...
I am currently taking levodopa or a similar medication.
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I am currently on a regular anti-nausea medication regimen.
Select...
My tumor is located in the front part of my pituitary gland.
Select...
I have a genetic condition that affects my heart's rhythm.
Select...
I have received chemotherapy that can cause vomiting in the last 4 weeks.
Select...
I am scheduled for surgery with local or regional anesthesia, or general anesthesia using propofol.
Select...
I am not allergic to amisulpride, dexamethasone, or ondansetron.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate Complete Response
Secondary study objectives
Operative Surgical Procedures
Key pharmacokinetics parameter - Peak Plasma Concentration
Key pharmacokinetics parameter - Total Exposure
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasoneExperimental Treatment2 Interventions
Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone
Group II: Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasoneExperimental Treatment2 Interventions
Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Acacia Pharma LtdLead Sponsor
17 Previous Clinical Trials
4,250 Total Patients Enrolled
7 Trials studying Postoperative Nausea and Vomiting
1,781 Patients Enrolled for Postoperative Nausea and Vomiting
Amicus CD LLCUNKNOWN
Premier Research Group plcIndustry Sponsor
63 Previous Clinical Trials
73,498 Total Patients Enrolled
Kumar Belani, MDPrincipal InvestigatorUniversity of Minnesota Masonic Children's Hospital
1 Previous Clinical Trials
231 Total Patients Enrolled