A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population

NCT06585540 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CRP23057
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Nausea and Vomiting

Keywords

Post Operative Nausea and Vomiting; Bariatric Surgery; Bariatric; Barhemsys; Amisulpride

Outcome Measures

Primary Outcomes (1)

• Number of Participants With "Complete Response" in the Post Anesthesia Care Unit

  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.

  Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes)

Secondary Outcomes (6)

• Incidence of complete response to established Post-operative Nausea and Vomiting

  Until Patient leave Post Anesthesia Care Unit (60-90 minutes)

• Number of participants with no nausea

  Up to 24 hours following surgery

• Number of Participants with no Emesis

  Up to 24 hours following surgery

• Number of Participants With no Use of Rescue Medication

  Up to 24 hours following surgery

• The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication

  Up to 24 hours following surgery

Study Arms (4)

Group Barhemsys

EXPERIMENTAL

Interventional arm receiving Barhemsys during surgery

Drug: Amisulpride IV Prevention

Group Placebo

PLACEBO COMPARATOR

Placebo arm receiving Placebo during surgery

Drug: Placebo Preventative

Group Placebo Barhemsys

EXPERIMENTAL

Of patients who are members of Group Placebo they will be able to receive Barhemsys in the Post Anesthesia Care Unit if they experience nausea or emesis

Drug: Amisulpride IV Treatment

Group Placebo Placebo

PLACEBO COMPARATOR

Of patients who are members of Group Placebo they will be able to receive Placebo in the Post Anesthesia Care Unit if they experience nausea or emesis

Drug: Placebo Treatment

Interventions

Amisulpride IV Prevention DRUG

Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia

Also known as: Amisulpride IV Treatment

Group Barhemsys

Amisulpride IV Treatment DRUG

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.

Group Placebo Barhemsys

Placebo Preventative DRUG

Patients in this arm will receive placebo (Normal Saline) while under general anesthesia

Group Placebo

Placebo Treatment DRUG

Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit

Group Placebo Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

Related Publications (10)

• Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.

  PMID: 20037151 BACKGROUND

• Berger ER, Huffman KM, Fraker T, Petrick AT, Brethauer SA, Hall BL, Ko CY, Morton JM. Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Ann Surg. 2018 Jan;267(1):122-131. doi: 10.1097/SLA.0000000000002079.

  PMID: 27849660 BACKGROUND

• Habib AS, Kranke P, Bergese SD, Chung F, Ayad S, Siddiqui N, Motsch J, Leiman DG, Melson TI, Diemunsch P, Fox GM, Candiotti KA. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. Anesthesiology. 2019 Feb;130(2):203-212. doi: 10.1097/ALN.0000000000002509.

  PMID: 30475232 BACKGROUND

• Candiotti KA, Kranke P, Bergese SD, Melson TI, Motsch J, Siddiqui N, Chung F, Rodriguez Y, Minkowitz HS, Ayad SS, Diemunsch P, Fox G. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg. 2019 Jun;128(6):1098-1105. doi: 10.1213/ANE.0000000000003733.

  PMID: 31094774 BACKGROUND

• Fox GM, Albayaty M, Walker JL, Xue H, Darpo B. Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2021 Jan;132(1):150-159. doi: 10.1213/ANE.0000000000004538.

  PMID: 31913911 BACKGROUND

• Apfel CC, Philip BK, Cakmakkaya OS, Shilling A, Shi YY, Leslie JB, Allard M, Turan A, Windle P, Odom-Forren J, Hooper VD, Radke OC, Ruiz J, Kovac A. Who is at risk for postdischarge nausea and vomiting after ambulatory surgery? Anesthesiology. 2012 Sep;117(3):475-86. doi: 10.1097/ALN.0b013e318267ef31.

  PMID: 22846680 BACKGROUND

• Carroll NV, Miederhoff P, Cox FM, Hirsch JD. Postoperative nausea and vomiting after discharge from outpatient surgery centers. Anesth Analg. 1995 May;80(5):903-9. doi: 10.1097/00000539-199505000-00009.

  PMID: 7726432 BACKGROUND

• White PF, O'Hara JF, Roberson CR, Wender RH, Candiotti KA; POST-OP Study Group. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008 Aug;107(2):452-8. doi: 10.1213/ane.0b013e31817b842c.

  PMID: 18633023 BACKGROUND

• Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.

  PMID: 32467512 BACKGROUND

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

  PMID: 10485781 BACKGROUND

Related Links

• FDA label for Amisulpride

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin S Liberman, Medical Doctor

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin S Liberman, Medical Doctor

CONTACT

206-341-1298; justin.liberman@vmfh.org

David B Auyong, Medical Doctor

CONTACT

206-341-1298; David.Auyong@vmfh.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, Department of Anesthesia

Model Details: Prospective, randomized, subject blinded, placebo-controlled crossover pilot study.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: September 13, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (1)