Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Participants With PONV-related Delay of Hospital Discharge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (18 years and older) undergoing LSG
排除标准
- •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
研究组 & 干预措施
Intervention Arm
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.
干预措施: Aprepitant 80 mg Oral Capsule (Drug)
Intervention Arm
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.
干预措施: scopolamine transdermal (Drug)
Intervention Arm
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.
干预措施: Total intravenous anesthesia (Procedure)
Intervention Arm
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.
干预措施: Dexamethasone (Drug)
Intervention Arm
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.
干预措施: Ondansetron (Drug)
Intervention Arm
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.
干预措施: Reglan (Drug)
Intervention Arm
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.
干预措施: Compazine (Drug)
Intervention Arm
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.
干预措施: Sugammadex (Drug)
Intervention Arm
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.
干预措施: Propofol (Drug)
Intervention Arm
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.
干预措施: dexmedetomidine (Drug)
Intervention Arm
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.
干预措施: Fentanyl (Drug)
Control Arm
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.
干预措施: Dexamethasone (Drug)
Control Arm
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.
干预措施: Ondansetron (Drug)
Control Arm
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.
干预措施: Reglan (Drug)
Control Arm
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.
干预措施: Compazine (Drug)
Control Arm
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.
干预措施: Sugammadex (Drug)
Control Arm
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.
干预措施: Sevoflurane (Drug)
Control Arm
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.
干预措施: Desflurane (Drug)
结局指标
主要结局
Number of Participants With PONV-related Delay of Hospital Discharge
时间窗: 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.
次要结局
- Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument(Baseline, 24 hours and 3 weeks)
- Severity of PONV Measured Using a 10-point Verbal Rating Scale.(Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks)
- Severity of PONV Measured Using the Rhodes Index(Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks)
- Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey(24 hours and 3 weeks)
- GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey(Baseline, 24 hours and 3 weeks)
研究者
Konstantinos Spaniolas
Associate Professor of Surgery, School of Medicine Bariatric, Foregut and Advanced GI Surgery
Stony Brook University