Post Operative Nausea and VomitingPhase 3NCT06585540
A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population
A Phase 3 study testing Amisulpride IV Prevention and Amisulpride IV Treatment in people with Post Operative Nausea and Vomiting, run by Benaroya Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Nausea and Vomiting
- What is being tested?
- Amisulpride IV Prevention and Amisulpride IV Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
Justin S Liberman, MD MPH, 206-341-1298, justin.liberman@vmfh.org
David B Auyong, MD, 206-341-1298, David.Auyong@vmfh.org
About this study
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.
Read the 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.
- Conditions
- Post Operative Nausea and Vomiting
- Being tested
- Amisulpride IV Prevention, Amisulpride IV Treatment, Placebo Preventative, Placebo Treatment
- Keywords
- Post Operative Nausea and Vomiting, Bariatric Surgery, Bariatric, Barhemsys, Amisulpride
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride IV PreventionDrug
Also called Amisulpride IV Treatment
Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia
Amisulpride IV TreatmentDrug
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.
Placebo PreventativeDrug
Patients in this arm will receive placebo (Normal Saline) while under general anesthesia
Placebo TreatmentDrug
Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit
| Study group | Role | What they receive |
|---|---|---|
| Group Barhemsys | Experimental | Interventional arm receiving Barhemsys during surgery Receives: Drug: Amisulpride IV Prevention |
| Group Placebo | Placebo comparator | Placebo arm receiving Placebo during surgery Receives: 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 Receives: 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 Receives: Drug: Placebo Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes)
Secondary outcomes (6)
Incidence of complete response to established Post-operative Nausea and Vomiting
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.
Measured: Until Patient leave Post Anesthesia Care Unit (60-90 minutes)
Number of participants with no nausea
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.
Measured: Up to 24 hours following surgery
Number of Participants with no Emesis
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)
Measured: Up to 24 hours following surgery
Number of Participants With no Use of Rescue Medication
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.
Measured: Up to 24 hours following surgery
The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication
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.
Measured: Up to 24 hours following surgery
The Number of Participants With no Significant Nausea
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.
Measured: Up to 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start13 Sep 2024
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post Operative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, subject blinded, placebo-controlled crossover pilot study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Responsible party
- Principal investigator, Justin Liberman, Benaroya Research Institute
- Investigators
- Justin S Liberman, Medical Doctor, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585540
- Sponsor's protocol ID
- CRP23057
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share IPD would only be required if the researches felt that information could be used to improve patient safety. This information would be shared with the FDA.
Publications
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.
PubMed 20037151Berger 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.
PubMed 27849660Habib 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.
PubMed 30475232Candiotti 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.
PubMed 31094774Fox 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.
PubMed 31913911Apfel 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.
PubMed 22846680Carroll 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.
PubMed 7726432White 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.
PubMed 18633023Gan 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.
PubMed 32467512Apfel 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.
PubMed 10485781
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population
- ClinicalTrials.gov ID
- NCT06585540
- Acronym / sponsor ID
- CRP23057
- Conditions
- Post Operative Nausea and Vomiting
- Keywords
- Post Operative Nausea and Vomiting, Bariatric Surgery, Bariatric, Barhemsys, Amisulpride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Prospective, randomized, subject blinded, placebo-controlled crossover pilot study.
| Arm | Type | Receives |
|---|---|---|
| Group Barhemsys | Experimental | Drug: Amisulpride IV PreventionInterventional arm receiving Barhemsys during surgery |
| Group Placebo | Placebo comparator | Drug: Placebo PreventativePlacebo arm receiving Placebo during surgery |
| Group Placebo Barhemsys | Experimental | Drug: Amisulpride IV TreatmentOf 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 |
| Group Placebo Placebo | Placebo comparator | Drug: Placebo TreatmentOf 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amisulpride IV PreventionAlso: Amisulpride IV TreatmentPatients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia | Drug | Group Barhemsys |
| Amisulpride IV TreatmentPatients in this arm will receive Amisulpride 10mg IV for first-line treatment of Post-Operative Nausea and Vomiting in the post-anesthesia care unit. | Drug | Group Placebo Barhemsys |
| Placebo PreventativePatients in this arm will receive placebo (Normal Saline) while under general anesthesia | Drug | Group Placebo |
| Placebo TreatmentPatients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit | Drug | Group Placebo Placebo |
Primary outcome
Number of Participants With "Complete Response" in the Post Anesthesia Care Unit
Time frame: 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.
6 secondary outcomes
Incidence of complete response to established Post-operative Nausea and Vomiting
Time frame: Until Patient leave Post Anesthesia Care Unit (60-90 minutes)
Number of participants with no nausea
Time frame: Up to 24 hours following surgery
Number of Participants with no Emesis
Time frame: Up to 24 hours following surgery
Number of Participants With no Use of Rescue Medication
Time frame: Up to 24 hours following surgery
The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication
Time frame: Up to 24 hours following surgery
The Number of Participants With no Significant Nausea
Time frame: Up to 24 hours following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Results publication: PubMed 20037151Wengritzky 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.
- Results publication: PubMed 27849660Berger 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.
- Results publication: PubMed 30475232Habib 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.
- Results publication: PubMed 31094774Candiotti 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.
- Results publication: PubMed 31913911Fox 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.
- Results publication: PubMed 22846680Apfel 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.
- Results publication: PubMed 7726432Carroll 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.
- Results publication: PubMed 18633023White 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.
- Results publication: PubMed 32467512Gan 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.
- Results publication: PubMed 10485781Apfel 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.
- FDA label for AmisulprideLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision to share IPD would only be required if the researches felt that information could be used to improve patient safety. This information would be shared with the FDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin S Liberman, Medical Doctor principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amisulpride IV Prevention and Amisulpride IV Treatment in people with Post Operative Nausea and Vomiting, run by Benaroya Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin S Liberman, Medical Doctor (206-341-1298, justin.liberman@vmfh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With "Complete Response" in the Post Anesthesia Care Unit (time frame: Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585540, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.