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

Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435003
• Other study ID #: 1074296-3
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: February 2024
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 1, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Sleeve Gastrectomy
• Nausea
• Post-operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant 80 mg Oral Capsule
aprepitant 80 mg orally one hour prior to scheduled surgery
• scopolamine transdermal
scopolamine transdermal patch one hour prior to scheduled surgery

Procedure:
• Total intravenous anesthesia
Maintenance of anesthesia without the use of inhaled anesthetics.

Drug:
• Dexamethasone
Dexamethasone 8 mg intraoperatively
• Ondansetron
Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
• Reglan
Postoperatively scheduled Reglan
• Ondansetron
Postoperatively scheduled ondansetron
• Compazine
Postoperatively as needed compazine for breakthrough PONV
• Sugammadex
Reversal with sugammadex
• Propofol
Intravenous anesthesia will be maintained through IV propofol
• dexmedetomidine
maintenance of anesthesia in the intervention arm
• Fentanyl
intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
• Sevoflurane
inhalational anesthesia
• Desflurane
inhalational anesthesia

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 1 week post-operation (up to 2 weeks from baseline)
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.	Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
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 .	Baseline, 1 hour, 4 hours, 12 hours, 24 hours and 3 weeks
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.	24 hours and 3 weeks
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.	Baseline, 24 hours and 3 weeks
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.	Baseline, 24 hours and 3 weeks