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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2019-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-operative Nausea and Vomiting Laparoscopic Sleeve Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Aprepitant 80 mg Oral Capsule

Intervention Type DRUG

aprepitant 80 mg orally one hour prior to scheduled surgery

scopolamine transdermal

Intervention Type DRUG

scopolamine transdermal patch one hour prior to scheduled surgery

Total intravenous anesthesia

Intervention Type PROCEDURE

Maintenance of anesthesia without the use of inhaled anesthetics.

Dexamethasone

Intervention Type DRUG

Dexamethasone 8 mg intraoperatively

Ondansetron

Intervention Type DRUG

Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.

Reglan

Intervention Type DRUG

Postoperatively scheduled Reglan

Ondansetron

Intervention Type DRUG

Postoperatively scheduled ondansetron

Compazine

Intervention Type DRUG

Postoperatively as needed compazine for breakthrough PONV

Sugammadex

Intervention Type DRUG

Reversal with sugammadex

Propofol

Intervention Type DRUG

Intravenous anesthesia will be maintained through IV propofol

dexmedetomidine

Intervention Type DRUG

maintenance of anesthesia in the intervention arm

Fentanyl

Intervention Type DRUG

intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 8 mg intraoperatively

Ondansetron

Intervention Type DRUG

Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.

Reglan

Intervention Type DRUG

Postoperatively scheduled Reglan

Ondansetron

Intervention Type DRUG

Postoperatively scheduled ondansetron

Compazine

Intervention Type DRUG

Postoperatively as needed compazine for breakthrough PONV

Sugammadex

Intervention Type DRUG

Reversal with sugammadex

Sevoflurane

Intervention Type DRUG

inhalational anesthesia

Desflurane

Intervention Type DRUG

inhalational anesthesia

Interventions

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Aprepitant 80 mg Oral Capsule

aprepitant 80 mg orally one hour prior to scheduled surgery

Intervention Type DRUG

scopolamine transdermal

scopolamine transdermal patch one hour prior to scheduled surgery

Intervention Type DRUG

Total intravenous anesthesia

Maintenance of anesthesia without the use of inhaled anesthetics.

Intervention Type PROCEDURE

Dexamethasone

Dexamethasone 8 mg intraoperatively

Intervention Type DRUG

Ondansetron

Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.

Intervention Type DRUG

Reglan

Postoperatively scheduled Reglan

Intervention Type DRUG

Ondansetron

Postoperatively scheduled ondansetron

Intervention Type DRUG

Compazine

Postoperatively as needed compazine for breakthrough PONV

Intervention Type DRUG

Sugammadex

Reversal with sugammadex

Intervention Type DRUG

Propofol

Intravenous anesthesia will be maintained through IV propofol

Intervention Type DRUG

dexmedetomidine

maintenance of anesthesia in the intervention arm

Intervention Type DRUG

Fentanyl

intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance

Intervention Type DRUG

Sevoflurane

inhalational anesthesia

Intervention Type DRUG

Desflurane

inhalational anesthesia

Intervention Type DRUG

Other Intervention Names

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Emend Transderm Scop Zofran Metoclopramide Zofran Compro Bridion Diprivan Precedex Ultane

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes