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Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

Primary Purpose

C.Surgical Procedure; Gastrointestinal

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl
palonosetron, dexamethasone, and 0.9% NaCl
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for C.Surgical Procedure; Gastrointestinal focused on measuring postoperative nausea and vomiting, fosaprepitant,

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age โ‰ฅ18 years and Age โ‰ค75 years;
  • Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;
  • The score evaluated by Apfel simplified PONV risk assessment systems is โ‰ฅ3.

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.

Sites / Locations

  • The Sixth Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

triple therapy

double therapy

Arm Description

Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered

double combination of Palonosetron and Dexamethasone were administered

Outcomes

Primary Outcome Measures

Proportion of participants with PONV during the first 24 postoperative hours
PONV is defined as nausea, retching or vomiting

Secondary Outcome Measures

Proportion of participants with PONV
PONV is defined as nausea, retching or vomiting
Proportion of participants with emetic episodes
Emetic episodes are defined as retching or vomiting or both
Proportion of participants with nausea
Nausea is defined as a feeling of the urge to vomit
Proportion of participants with rescue antiemetic medication
Rescue antiemetic medication
The severity of PONV
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
Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours)
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.
Pain scores
Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10).
Time to first flatus after surgery
Time length between operation completion and the first flatus
Time to first defecation after surgery
Time length between operation completion and the first defecation
Time to fulfill the criteria of hospital discharge (recovery time)
The ideal time point for discharge, which is also considered as recovery time.
Health related quality of life
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.
Proportion of patients with adverse events (up to 30 days after surgery)
adverse events

Full Information

First Posted
April 20, 2021
Last Updated
December 26, 2022
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04853147
Brief Title
Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C.Surgical Procedure; Gastrointestinal
Keywords
postoperative nausea and vomiting, fosaprepitant,

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
triple therapy
Arm Type
Experimental
Arm Description
Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered
Arm Title
double therapy
Arm Type
Other
Arm Description
double combination of Palonosetron and Dexamethasone were administered
Intervention Type
Drug
Intervention Name(s)
palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl
Other Intervention Name(s)
Triple therapy
Intervention Description
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,
Intervention Type
Drug
Intervention Name(s)
palonosetron, dexamethasone, and 0.9% NaCl
Other Intervention Name(s)
double therapy
Intervention Description
palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
Primary Outcome Measure Information:
Title
Proportion of participants with PONV during the first 24 postoperative hours
Description
PONV is defined as nausea, retching or vomiting
Time Frame
from operation completion to 24-hour after surgery (up to 24 hours)
Secondary Outcome Measure Information:
Title
Proportion of participants with PONV
Description
PONV is defined as nausea, retching or vomiting
Time Frame
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Title
Proportion of participants with emetic episodes
Description
Emetic episodes are defined as retching or vomiting or both
Time Frame
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Title
Proportion of participants with nausea
Description
Nausea is defined as a feeling of the urge to vomit
Time Frame
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Title
Proportion of participants with rescue antiemetic medication
Description
Rescue antiemetic medication
Time Frame
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Title
The severity of PONV
Description
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
Time Frame
calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery)
Title
Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours)
Description
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.
Time Frame
evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Title
Pain scores
Description
Pain scores are evaluated by numerical rating scale(NRS) from no pain(0) to most severe pain (10).
Time Frame
evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery)
Title
Time to first flatus after surgery
Description
Time length between operation completion and the first flatus
Time Frame
evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery)
Title
Time to first defecation after surgery
Description
Time length between operation completion and the first defecation
Time Frame
evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery
Title
Time to fulfill the criteria of hospital discharge (recovery time)
Description
The ideal time point for discharge, which is also considered as recovery time.
Time Frame
from operation completion to fulfill the criteria of hospital discharge(expected 6 days )
Title
Health related quality of life
Description
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.
Time Frame
evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days๏ผ‰
Title
Proportion of patients with adverse events (up to 30 days after surgery)
Description
adverse events
Time Frame
from drug administration to 30 days (30 days)
Other Pre-specified Outcome Measures:
Title
Concentration of materials in blood such as hormone and metabolic
Description
materials in blood
Time Frame
evaluated before surgery, at the end of surgery
Title
6-month survival rate
Description
survival rate in 6-month after surgery
Time Frame
6-month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age โ‰ฅ18 years and Age โ‰ค75 years; Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ; The score evaluated by Apfel simplified PONV risk assessment systems is โ‰ฅ3. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Zhao, Doctor
Organizational Affiliation
Sixth SunYetSen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

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