Post Operative Nausea and Vomiting
Conditions
Keywords
Post Operative Nausea and Vomiting, Bariatric Surgery, Bariatric, Barhemsys, Amisulpride
Brief summary
To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.
Detailed description
This is a phase III/IV, randomized, placebo-controlled, patient-blinded cross-over pilot study to evaluate the effectiveness of Amisulpride in the treatment and prevention of Post Operative Nausea and Vomiting (PONV) in adult patients, 18-65 years of age, at a single surgery site in the pacific northwest who are undergoing bariatric surgery. Approximately 100 patients will be randomized in a 1:1 ratio to receive a single intravenous dose of Amisulpride (5mg IV single dose) or a placebo (saline control, 1mL IV single dose) at the induction of anesthesia. Those who initially receive placebo will undergo an additional randomization in the post-anesthesia care unit (PACU) to receive a dose of Amisulpride (10mg IV single dose) or placebo (saline control, 2mL IV single dose) in a 1:1 ratio as first line treatment for PONV.
Interventions
DRUGAmisulpride IV Prevention
Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia
DRUGAmisulpride IV Treatment
Patients in this arm will receive Amisulpride 10mg IV for first-line treatment of Post-Operative Nausea and Vomiting in the post-anesthesia care unit.
DRUGPlacebo Preventative
Patients in this arm will receive placebo (Normal Saline) while under general anesthesia
DRUGPlacebo Treatment
Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit
Sponsors
Virginia Mason Hospital/Medical Center
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Prospective, randomized, subject blinded, placebo-controlled crossover pilot study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* The study will recruit adult patients (Age 18-65) scheduled for bariatric surgery. Additional inclusion criteria include ASA class I-III and patients who plan to be inpatient for at least 24 hours. Included Surgeries: Robotic, Laparoscopic or Open Roux-en-Y Robotic, Laparoscopic or Open Gastric Sleeve Robotic, Laparoscopic or Open Gastrectomy Robotic, Laparoscopic or Open Revision Gastric Bypass
Exclusion criteria
* Pregnant or breastfeeding * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Congenital QTc abnormalities * Current use of droperidol * Parkinson's disease * Allergy to Barhemsys * GFR < 30 mL/min/1.73m2 * Emergency surgery or add-on cases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response in the Post Anesthesia Care Unit | Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes) | Complete response is defined as no occurrence of vomiting or retching, no nausea score ≥ 1 and no use of rescue medication during their Post Anesthesia Care Unit stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with no nausea | Up to 24 hours following surgery | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. No nausea means no score ≥ 1. |
| Number of Participants with no Emesis | Up to 24 hours following surgery | Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach) |
| Incidence of complete response to established Post-operative Nausea and Vomiting | Until Patient leave Post Anesthesia Care Unit (60-90 minutes) | Effectiveness of Barhemsys in the treatment of established nausea or vomiting in the high-risk bariatric surgical population during Post Anesthesia Care Unit stay. Failure of complete response is defined as subject emesis or use of rescue medication during Post Anesthesia Care Unit stay following a treatment dose of Barhemsys. |
| The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication | Up to 24 hours following surgery | No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication. |
| The Number of Participants With no Significant Nausea | Up to 24 hours following surgery | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. No significant nausea means no score ≥ 4. |
| Number of Participants With no Use of Rescue Medication | Up to 24 hours following surgery | Any agent given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue antiemetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the postoperative period which would be expected, by virtue of its pharmacology, dosage, and route, to exert a clinically meaningful antiemetic effect was considered as rescue antiemetic medication, even if administered inadvertently or without the intention of providing rescue. |
Countries
United States
Contacts
Primary ContactJustin S Liberman, Medical Doctor
Backup ContactDavid B Auyong, Medical Doctor
Outcome results
None listed