| Primary | 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. | | Posted | | Count of Participants | | Participants | | up to 1 week post-operation (up to 2 weeks from baseline) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | 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 . | | Posted | | Mean | Full Range | score on a scale | | Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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. | | Posted | | Mean | Full Range | score on a scale | | 24 hours and 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 24 hours and 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | No | Baseline, 24 hours and 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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