Post-operative Nausea and VomitingPhase 4NCT03435003
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
A Phase 4 study testing Aprepitant 80 mg Oral Capsule, scopolamine transdermal and Total intravenous anesthesia in people with Post-operative Nausea and Vomiting and Laparoscopic Sleeve Gastrectomy, run by Stony Brook University at 1 site in United States.
Trial summary
Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Aprepitant 80 mg Oral Capsule, scopolamine transdermal and Total intravenous anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 1 Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (18 years and older) undergoing LSG
Who cannot join
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- History of chronic nausea and emesis requiring medication
- Poorly controlled diabetes (HgA1c>9 mg/dl),
- History of previous bariatric or gastro-esophageal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794-8191
About this study
Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.
Read the detailed description
To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life.
The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.
- Being tested
- Aprepitant 80 mg Oral Capsule, scopolamine transdermal, Total intravenous anesthesia, Dexamethasone, Ondansetron
- Keywords
- Bariatric Procedure
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant 80 mg Oral CapsuleDrug
Also called Emend
aprepitant 80 mg orally one hour prior to scheduled surgery
scopolamine transdermalDrug
Also called Transderm Scop
scopolamine transdermal patch one hour prior to scheduled surgery
Total intravenous anesthesiaProcedure or surgery
Maintenance of anesthesia without the use of inhaled anesthetics.
DexamethasoneDrug
Dexamethasone 8 mg intraoperatively
OndansetronDrug
Also called Zofran
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
ReglanDrug
Also called Metoclopramide
Postoperatively scheduled Reglan
OndansetronDrug
Also called Zofran
Postoperatively scheduled ondansetron
CompazineDrug
Also called Compro
Postoperatively as needed compazine for breakthrough PONV
SugammadexDrug
Also called Bridion
Reversal with sugammadex
PropofolDrug
Also called Diprivan
Intravenous anesthesia will be maintained through IV propofol
dexmedetomidineDrug
Also called Precedex
maintenance of anesthesia in the intervention arm
FentanylDrug
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
SevofluraneDrug
Also called Ultane
inhalational anesthesia
DesfluraneDrug
inhalational anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch.
B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. Receives: Drug: Aprepitant 80 mg Oral Capsule; Drug: scopolamine transdermal; Procedure: Total intravenous anesthesia; Drug: Dexamethasone; Drug: Ondansetron; Drug: Reglan; Drug: Compazine; Drug: Sugammadex; Drug: Propofol; Drug: dexmedetomidine; Drug: Fentanyl |
| Control Arm | Active comparator | A) Pre-operatively: No intervention
B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg.
C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. Receives: Drug: Dexamethasone; Drug: Ondansetron; Drug: Reglan; Drug: Compazine; Drug: Sugammadex; Drug: Sevoflurane; Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With PONV-related Delay of Hospital Discharge
The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
Measured: up to 1 week post-operation (up to 2 weeks from baseline)
Secondary outcomes (5)
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
The severity of PONV will be measured using a visual analogue scale. [0-10] The higher the value, the worse the outcome.
Measured: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Severity of PONV Measured Using the Rhodes Index
The Rhodes Index of Nausea, Vomiting, and Retching (R-INVR) is a validated instrument used to measure the severity of Post-Operative Nausea and Vomiting (PONV). The index comprises eight items, each scored on a scale of 0 to 4, allowing for a total score range of 0 to 32 points .
The scoring of each item on the Rhodes Index is as follows:
0 points represent a minimum level of disturbance, 4 points represent a maximum level of disturbance . The total score from these eight items is summed to represent the severity of PONV, with higher scores indicating worse PONV experience. The index encompasses three subscales named "experience," "occurrence," and "distress" . Each of these subscales contributes to the total score to provide a comprehensive measure of PONV severity. Any score above zero on the R-INVR indicates that the participant experienced nausea .
Measured: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. The higher the score, the worse the outcome.
Measured: 24 hours and 3 weeks
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
The GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice and clinical trials of patients with GI disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and sub-scores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life.
Measured: Baseline, 24 hours and 3 weeks
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
EQ-5D Descriptive System:
Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Levels: Each dimension has 5 severity levels:
- No problems
- Slight problems
- Moderate problems
- Severe problems
- Extreme problems
Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
Measured: Baseline, 24 hours and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start28 Aug 2017
- Primary completion30 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Spaniolas, Stony Brook University
- Investigators
- Konstantinos Spaniolas, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435003
- Sponsor's protocol ID
- 1074296-3
- Status last verified
- Feb 2024
- First submitted
- 14 Aug 2017
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.
PubMed 33528788
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03435003
- Acronym / sponsor ID
- 1074296-3
- Keywords
- Bariatric Procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.
Detailed description
To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life.
The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Aprepitant 80 mg Oral Capsule, Drug: scopolamine transdermal, Procedure: Total intravenous anesthesia, Drug: Dexamethasone, Drug: Ondansetron, Drug: Reglan, Drug: Compazine, Drug: Sugammadex, Drug: Propofol, Drug: dexmedetomidine, Drug: FentanylA) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch. B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. |
| Control Arm | Active comparator | Drug: Dexamethasone, Drug: Ondansetron, Drug: Reglan, Drug: Compazine, Drug: Sugammadex, Drug: Sevoflurane, Drug: DesfluraneA) Pre-operatively: No intervention B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years and older) undergoing LSG
Key exclusion criteria (5 listed)
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- History of chronic nausea and emesis requiring medication
- Poorly controlled diabetes (HgA1c>9 mg/dl),
- History of previous bariatric or gastro-esophageal surgery
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 |
|---|---|---|
| Aprepitant 80 mg Oral CapsuleAlso: Emendaprepitant 80 mg orally one hour prior to scheduled surgery | Drug | Intervention Arm |
| scopolamine transdermalAlso: Transderm Scopscopolamine transdermal patch one hour prior to scheduled surgery | Drug | Intervention Arm |
| Total intravenous anesthesiaMaintenance of anesthesia without the use of inhaled anesthetics. | Procedure or surgery | Intervention Arm |
| DexamethasoneDexamethasone 8 mg intraoperatively | Drug | Control Arm, Intervention Arm |
| OndansetronAlso: ZofranOndansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively. | Drug | Control Arm, Intervention Arm |
| ReglanAlso: MetoclopramidePostoperatively scheduled Reglan | Drug | Control Arm, Intervention Arm |
| OndansetronAlso: ZofranPostoperatively scheduled ondansetron | Drug | Control Arm, Intervention Arm |
| CompazineAlso: ComproPostoperatively as needed compazine for breakthrough PONV | Drug | Control Arm, Intervention Arm |
| SugammadexAlso: BridionReversal with sugammadex | Drug | Control Arm, Intervention Arm |
| PropofolAlso: DiprivanIntravenous anesthesia will be maintained through IV propofol | Drug | Intervention Arm |
| dexmedetomidineAlso: Precedexmaintenance of anesthesia in the intervention arm | Drug | Intervention Arm |
| Fentanylintermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance | Drug | Intervention Arm |
| SevofluraneAlso: Ultaneinhalational anesthesia | Drug | Control Arm |
| Desfluraneinhalational anesthesia | Drug | Control Arm |
Primary outcome
Number of Participants With PONV-related Delay of Hospital Discharge
Time frame: up to 1 week post-operation (up to 2 weeks from baseline)
The primary outcome would be incidence of PONV-related delay of hospital discharge following laparoscopic gastrectomy. Based on the current clinical pathway, patients are expected to be discharged on postoperative day 1 (day after surgery). A delay in discharge due to PONV will be the primary outcome.
5 secondary outcomes
Severity of PONV Measured Using a 10-point Verbal Rating Scale.
Time frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Severity of PONV Measured Using the Rhodes Index
Time frame: Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey
Time frame: 24 hours and 3 weeks
GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey
Time frame: Baseline, 24 hours and 3 weeks
Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument
Time frame: Baseline, 24 hours and 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33528788Naeem Z, Nie L, Drakos P, Yang J, Gan TJ, Pryor AD, Spaniolas K. The Relationship Between Postoperative Nausea and Vomiting and Early Self-Rated Quality of Life Following Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2021 Aug;25(8):2107-2109. doi: 10.1007/s11605-021-04923-4. Epub 2021 Feb 2. No abstract available.
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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.
Konstantinos Spaniolas, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant 80 mg Oral Capsule, scopolamine transdermal and Total intravenous anesthesia in people with Post-operative Nausea and Vomiting and Laparoscopic Sleeve Gastrectomy, run by Stony Brook University 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With PONV-related Delay of Hospital Discharge (time frame: up to 1 week post-operation (up to 2 weeks from baseline)). 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 NCT03435003, which also lists 1 linked publication.
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 14 Feb 2024.