Phase 4
N=83
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Post-operative Nausea and Vomiting · Laparoscopic Sleeve Gastrectomy
Bottom Line
View on ClinicalTrials.gov: NCT03435003 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With PONV-related Delay of Hospital Discharge — 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aprepitant 80 mg Oral Capsule (Drug); scopolamine transdermal (Drug); Total intravenous anesthesia (Procedure); Dexamethasone (Drug); Ondansetron (Drug); Reglan (Drug); Compazine (Drug); Sugammadex (Drug); Propofol (Drug); dexmedetomidine (Drug); Fentanyl (Drug); Sevoflurane (Drug); Desflurane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With PONV-related Delay of Hospital Discharge |
0; 4 | — |
| SECONDARY Severity of PONV Measured Using a 10-point Verbal Rating Scale. |
0.12; 0.10; 2.29; 3.68; 1.46; 2.76 | — |
| SECONDARY Severity of PONV Measured Using the Rhodes Index |
0.08; 0.19; 1.79; 6.17; 0.69; 5.26 | — |
| SECONDARY Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey |
120.59; 109.29; 137.53; 130.64 | — |
| SECONDARY GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey |
108.34; 107.52; 100.71; 98.03 | — |
| SECONDARY Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument |
29; 29; 7; 8; 3; 5 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Adult patients (18 years and older) undergoing LSG
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03435003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.