Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

December 26, 2022 updated by: YangZhao, Sixth Affiliated Hospital, Sun Yat-sen University

Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery

Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent PONV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of patients will be evaluated. The primary outcome is proportion of participants with PONV during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.

Study Type

Interventional

Enrollment (Actual)

1154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The sixth affiliated hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years and Age ≤75 years;
  • Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;
  • The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.

Exclusion Criteria:

  • The American Society of Anesthesiologists (ASA) rating is >3;
  • Severe hepatic dysfunction(the score of Child-Pugh is >9);
  • With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ;
  • Take medications with known antiemetic properties preoperatively ;
  • With mental disorder, or not be able to communicate ;
  • Pregnant women or nursing mothers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: triple therapy
Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered
Drug: palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,
Other Names:
  • Triple therapy
Other: double therapy
double combination of Palonosetron and Dexamethasone were administered
Drug: palonosetron, dexamethasone, and 0.9% NaCl
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
Other Names:
  • double therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with PONV during the first 24 postoperative hours
Time Frame: from operation completion to 24-hour after surgery (up to 24 hours)
PONV is defined as nausea, retching or vomiting
from operation completion to 24-hour after surgery (up to 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with PONV
Time Frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
PONV is defined as nausea, retching or vomiting
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with emetic episodes
Time Frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Emetic episodes are defined as retching or vomiting or both
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with nausea
Time Frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Nausea is defined as a feeling of the urge to vomit
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Proportion of participants with rescue antiemetic medication
Time Frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Rescue antiemetic medication
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
The severity of PONV
Time Frame: calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
The severity of PONV is evaluated by a PONV impact scale score. Nausea intensity is scored as 1 ,2 ,3. In addition, vomiting intensity is scored as the number of vomits (0-2, or 3 if three or more vomits). Both scores together to obtain the PONV impact scale score
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours)
Time Frame: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
The QoR-15 comprises five subscales: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150. A higher total score means better patient QoR.
evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Pain scores
Time Frame: evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10).
evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Time to first flatus after surgery
Time Frame: evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery)
Time length between operation completion and the first flatus
evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery)
Time to first defecation after surgery
Time Frame: evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery
Time length between operation completion and the first defecation
evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery
Time to fulfill the criteria of hospital discharge (recovery time)
Time Frame: from operation completion to fulfill the criteria of hospital discharge(expected 6 days )
The ideal time point for discharge, which is also considered as recovery time.
from operation completion to fulfill the criteria of hospital discharge(expected 6 days )
Health related quality of life
Time Frame: evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days）
Health related quality of life is measured by EQ-5D. Each EQ-5D health state can be coded into a five-digit number using the numbers 1 , 2 , and 3 to indicate the functional levels of the five dimensions.
evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days）
Proportion of patients with adverse events (up to 30 days after surgery)
Time Frame: from drug administration to 30 days (30 days)
adverse events
from drug administration to 30 days (30 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of materials in blood such as hormone and metabolic
Time Frame: evaluated before surgery, at the end of surgery
materials in blood
evaluated before surgery, at the end of surgery
6-month survival rate
Time Frame: 6-month after surgery
survival rate in 6-month after surgery
6-month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Yang Zhao, Doctor, Sixth SunYetSen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

April 13, 2022

Study Completion (Actual)

October 12, 2022

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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