A Phase 4 interventional study of Aprepitant 80 mg Oral Capsule and scopolamine transdermal in Post-operative Nausea and Vomiting and Laparoscopic Sleeve Gastrectomy, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by Stony Brook University · Phase 4, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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.
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
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.
Drug: Dexamethasone · Drug: Ondansetron · Drug: Reglan · Drug: Compazine · Drug: Sugammadex · Drug: Sevoflurane · Drug: Desflurane
aprepitant 80 mg orally one hour prior to scheduled surgery
Also known as: Emend
scopolamine transdermal patch one hour prior to scheduled surgery
Also known as: Transderm Scop
Maintenance of anesthesia without the use of inhaled anesthetics.
Dexamethasone 8 mg intraoperatively
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
Also known as: Zofran
Postoperatively scheduled Reglan
Also known as: Metoclopramide
Postoperatively scheduled ondansetron
Also known as: Zofran
Postoperatively as needed compazine for breakthrough PONV
Also known as: Compro
Reversal with sugammadex
Also known as: Bridion
Intravenous anesthesia will be maintained through IV propofol
Also known as: Diprivan
maintenance of anesthesia in the intervention arm
Also known as: Precedex
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
inhalational anesthesia
Also known as: Ultane
inhalational anesthesia
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.
Time frame: up to 1 week post-operation (up to 2 weeks from baseline)
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.
Time frame: 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 .
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
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.
Time frame: 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.
Time frame: 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: 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. Extreme problems Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
Time frame: Baseline, 24 hours and 3 weeks
| Milestone | Intervention Arm | Control Arm |
|---|---|---|
| Started | 41 | 42 |
| Completed | 41 | 42 |
| Not completed | 0 | 0 |
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.
| Participants | Intervention Arm | Control Arm |
|---|---|---|
| Number of Participants With PONV-related Delay of Hospital Discharge | 0 | 4 |
The severity of PONV will be measured using a visual analogue scale. \[0-10\] The higher the value, the worse the outcome.
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 0.12 ± 0.56 | 0.10 ± 0.43 |
| 1 hr | 2.29 ± 2.86 | 3.68 ± 3.45 |
| 4 hr | 1.46 ± 1.82 | 2.76 ± 2.97 |
| 12 hr | 0.69 ± 1.47 | 2.19 ± 2.63 |
| 24 hr | 0.44 ± 1.16 | 1.80 ± 2.89 |
| 3 week | 0.15 ± 0.43 | 0.58 ± 1.68 |
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 .
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 0.08 (0 to 3) | 0.19 (0 to 4) |
| 12 hr | 1.79 (0 to 8) | 6.17 (0 to 24) |
| 24 hr | 0.69 (0 to 6) | 5.26 (0 to 23) |
| 3 weeks | 0.13 (0 to 3) | 1.42 (0 to 4) |
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.
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| 24 hr | 120.59 (86 to 147) | 109.29 (59 to 146) |
| 3 weeks | 137.53 (78 to 150) | 130.64 (61 to 150) |
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.
| score on a scale | Intervention Arm | Control Arm |
|---|---|---|
| Baseline | 108.34 ± 12.49 | 107.52 ± 13.35 |
| 3 Weeks | 100.71 ± 20.60 | 98.03 ± 25.22 |
EQ-5D Descriptive System: Dimensions: Includes five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Levels: Each dimension has 5 severity levels: 1. No problems 2. Slight problems 3. Moderate problems 4. Severe problems 5. Extreme problems Time Frame: Assessed at baseline, 24 hours post-baseline, and 3 weeks.
| Participants | Intervention Arm | Control Arm |
|---|---|---|
| Baseline: Usual activities — None | 29 | 29 |
| Baseline: Usual activities — Slight | 7 | 8 |
| Baseline: Usual activities — Moderate | 3 | 5 |
| Baseline: Usual activities — Severe | 2 | 0 |
| Baseline: Usual activities — Unable | 0 | 0 |
| Baseline: Usual activities — Not Reported | 0 | 0 |
| Baseline: Anxiety/depression — None | 26 | 29 |
| Baseline: Anxiety/depression — Slight | 11 | 10 |
| Baseline: Anxiety/depression — Moderate | 4 | 2 |
| Baseline: Anxiety/depression — Severe | 0 | 1 |
| Baseline: Anxiety/depression — Unable | 0 | 0 |
| Baseline: Anxiety/depression — Not Reported | 0 | 0 |
| Baseline: Mobility — None | 36 | 29 |
| Baseline: Mobility — Slight | 2 | 6 |
| Baseline: Mobility — Moderate | 2 | 6 |
| Baseline: Mobility — Severe | 1 | 1 |
| Baseline: Mobility — Unable | 0 | 0 |
| Baseline: Mobility — Not Reported | 0 | 0 |
| Baseline: Pain/discomfort — None | 24 | 20 |
| Baseline: Pain/discomfort — Slight | 12 | 13 |
| Baseline: Pain/discomfort — Moderate | 4 | 6 |
| Baseline: Pain/discomfort — Severe | 0 | 3 |
| Baseline: Pain/discomfort — Unable | 1 | 0 |
| Baseline: Pain/discomfort — Not Reported | 0 | 0 |
| Baseline: Self-care — None | 37 | 38 |
| Baseline: Self-care — Slight | 2 | 3 |
| Baseline: Self-care — Moderate | 1 | 1 |
| Baseline: Self-care — Severe | 1 | 0 |
| Baseline: Self-care — Unable | 0 | 0 |
| Baseline: Self-care — Not Reported | 0 | 0 |
| 24 h: Usual activities — None | 11 | 15 |
| 24 h: Usual activities — Slight | 13 | 9 |
| 24 h: Usual activities — Moderate | 5 | 3 |
| 24 h: Usual activities — Severe | 1 | 3 |
| 24 h: Usual activities — Unable | 2 | 5 |
| 24 h: Usual activities — Not Reported | 9 | 7 |
| 24 h: Anxiety/depression — None | 29 | 25 |
| 24 h: Anxiety/depression — Slight | 3 | 7 |
| 24 h: Anxiety/depression — Moderate | 0 | 3 |
| 24 h: Anxiety/depression — Severe | 0 | 0 |
| 24 h: Anxiety/depression — Unable | 0 | 0 |
| 24 h: Anxiety/depression — Not Reported | 9 | 7 |
| 24 h: Mobility — None | 25 | 27 |
| 24 h: Mobility — Slight | 6 | 3 |
| 24 h: Mobility — Moderate | 1 | 3 |
| 24 h: Mobility — Severe | 0 | 1 |
| 24 h: Mobility — Unable | 0 | 1 |
| 24 h: Mobility — Not Reported | 9 | 7 |
| 24 h: Pain/discomfort — None | 4 | 4 |
| 24 h: Pain/discomfort — Slight | 16 | 16 |
| 24 h: Pain/discomfort — Moderate | 12 | 14 |
| 24 h: Pain/discomfort — Severe | 0 | 1 |
| 24 h: Pain/discomfort — Unable | 0 | 0 |
| 24 h: Pain/discomfort — Not Reported | 9 | 7 |
| 24 h: Self-care — None | 22 | 26 |
| 24 h: Self-care — Slight | 5 | 4 |
| 24 h: Self-care — Moderate | 4 | 3 |
| 24 h: Self-care — Severe | 0 | 2 |
| 24 h: Self-care — Unable | 1 | 0 |
| 24 h: Self-care — Not Reported | 9 | 7 |
| 3 weeks: Usual activities — None | 37 | 25 |
| 3 weeks: Usual activities — Slight | 2 | 8 |
| 3 weeks: Usual activities — Moderate | 0 | 3 |
| 3 weeks: Usual activities — Severe | 1 | 0 |
| 3 weeks: Usual activities — Unable | 0 | 0 |
| 3 weeks: Usual activities — Not Reported | 1 | 6 |
| 3 weeks: Anxiety/depression — None | 33 | 28 |
| 3 weeks: Anxiety/depression — Slight | 6 | 6 |
| 3 weeks: Anxiety/depression — Moderate | 1 | 1 |
| 3 weeks: Anxiety/depression — Severe | 0 | 1 |
| 3 weeks: Anxiety/depression — Unable | 0 | 0 |
| 3 weeks: Anxiety/depression — Not Reported | 1 | 6 |
| 3 weeks: Mobility — None | 37 | 27 |
| 3 weeks: Mobility — Slight | 1 | 7 |
| 3 weeks: Mobility — Moderate | 2 | 1 |
| 3 weeks: Mobility — Severe | 0 | 1 |
| 3 weeks: Mobility — Unable | 0 | 0 |
| 3 weeks: Mobility — Not Reported | 1 | 6 |
| 3 weeks: Pain/discomfort — None | 23 | 16 |
| 3 weeks: Pain/discomfort — Slight | 14 | 13 |
| 3 weeks: Pain/discomfort — Moderate | 2 | 6 |
| 3 weeks: Pain/discomfort — Severe | 0 | 0 |
| 3 weeks: Pain/discomfort — Unable | 1 | 0 |
| 3 weeks: Pain/discomfort — Not Reported | 1 | 7 |
| 3 weeks: Self-care — None | 38 | 31 |
| 3 weeks: Self-care — Slight | 1 | 4 |
| 3 weeks: Self-care — Moderate | 1 | 1 |
| 3 weeks: Self-care — Severe | 0 | 0 |
| 3 weeks: Self-care — Unable | 0 | 0 |
| 3 weeks: Self-care — Not Reported | 1 | 6 |
Collected over From enrollment until the participants 3 week follow up post-operative appointment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Control Arm | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Continuous(years) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 41.3 ± 9.7 | 43 ± 13 | 42.2 ± 11.4 |
| Sex: Female, Male(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Female | 26 | 29 | 55 |
| Male | 15 | 13 | 28 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 29 | 33 | 62 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 12 | 9 | 21 |
| Previous history of postoperative nausea and vomiting (PONV)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
| Weight(lbs) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 292 ± 52 | 293 ± 61 | 292.5 ± 56.4 |
| BMI(kg/m2) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 47.3 ± 6.4 | 46.4 ± 7.5 | 46.8 ± 6.9 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stony Brook University