Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

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.

• Aprepitant 80 mg Oral Capsule (Drug), also known as Emend: aprepitant 80 mg orally one hour prior to scheduled surgery
• scopolamine transdermal (Drug), also known as Transderm Scop: scopolamine transdermal patch one hour prior to scheduled surgery
• Total intravenous anesthesia (Procedure): Maintenance of anesthesia without the use of inhaled anesthetics.
• Dexamethasone (Drug): Dexamethasone 8 mg intraoperatively
• Ondansetron (Drug), also known as Zofran: Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
• Reglan (Drug), also known as Metoclopramide: Postoperatively scheduled Reglan
• Ondansetron (Drug), also known as Zofran: Postoperatively scheduled ondansetron
• Compazine (Drug), also known as Compro: Postoperatively as needed compazine for breakthrough PONV
• Sugammadex (Drug), also known as Bridion: Reversal with sugammadex
• Propofol (Drug), also known as Diprivan: Intravenous anesthesia will be maintained through IV propofol
• dexmedetomidine (Drug), also known as Precedex: maintenance of anesthesia in the intervention arm
• Fentanyl (Drug): intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
• Sevoflurane (Drug), also known as Ultane: inhalational anesthesia
• Desflurane (Drug): inhalational anesthesia

Primary outcomes

• Number of Participants With PONV-related Delay of Hospital Discharge [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.

Secondary outcomes

• Severity of PONV Measured Using a 10-point Verbal Rating Scale. [Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks]: The severity of PONV will be measured using a visual analogue scale. \[0-10\] The higher the value, the worse the outcome.
• Severity of PONV Measured Using the Rhodes Index [Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks]: 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 .
• Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey [24 hours and 3 weeks]: 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.
• GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey [Baseline, 24 hours and 3 weeks]: 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.
• Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument [Baseline, 24 hours and 3 weeks]: 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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Number of Participants With PONV-related Delay of Hospital Discharge (Primary), Count of participants, Participants: Intervention Arm 0; Control Arm 4
• Severity of PONV Measured Using a 10-point Verbal Rating Scale. (Secondary), Mean, score on a scale: Intervention Arm 0.12 +/- 0.56; Control Arm 0.10 +/- 0.43
• Severity of PONV Measured Using the Rhodes Index (Secondary), Mean, score on a scale: Intervention Arm 0.08 (0 to 3); Control Arm 0.19 (0 to 4)
• Quality of Recovery Measured Using the Quality of Recovery QoR-15 Survey (Secondary), Mean, score on a scale: Intervention Arm 120.59 (86 to 147); Control Arm 109.29 (59 to 146)
• GI Specific Quality of Life Using the Gastrointestinal Quality of Life (GIQLI) Survey (Secondary), Mean, score on a scale: Intervention Arm 108.34 +/- 12.49; Control Arm 107.52 +/- 13.35
• Overall Quality of Life Using the EuroQol- 5 Dimension (EQ-5D) Instrument (Secondary), Count of participants, Participants: Intervention Arm 29; Control Arm 29

Adverse events

Time frame: From enrollment until the participants 3 week follow up post-operative appointment.

• Results publication: 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. PMID 33528788

• Study Protocol and Statistical Analysis Plan (PDF, 2019-05-22)
• Informed Consent Form (PDF, 2018-05-10)

• Konstantinos Spaniolas, MD, Principal investigator, Stony Brook University