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Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant as PONV Prevention

Primary Purpose

Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures, Laparoscopy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fosaprepitant
normal saline
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV, fosaprepitant, dexamethasone, palonosetron

Eligibility Criteria

19 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients undergoing laparoscopic gynecological surgery. Adults between the ages of 18 and 50 American Society of Anesthesiologists Physical Status (ASA physical status I, II Exclusion Criteria: American Association of Anesthesiologists physical standards (ASA physical status III or higher) Children under the age of 19 Adults over 49 years of age Diabetes Mellitus Pregnant or lactating women Patients with a history of allergy or contraindications for use of the study drug Patients who did not understand this study or expressed their refusal. Patients with a history of serious psychologic disease that may affect the patient evaluation Patients taking serotonergic drugs

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Dual therapy group

Triple therapy group

Arm Description

On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes. The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.

On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes. The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.

Outcomes

Primary Outcome Measures

the incidence of Postoperative nausea and vomiting
yes or no

Secondary Outcome Measures

the incidence of Postoperative nausea and vomiting
yes or no
the severity of Postoperative nausea and vomiting
numeric rating scale 0-10 and PONV impact scale
rescue antiemetics
dose
time to rescue antiemetics
the first administration time point of rescue antiemetics
postoperative pain at rest and couging
numeric rating scale 0-10
opioid consumption
morphine equivalent dose
Any adverse event
yes or no
Time to normal diet
time of succes of normal diet
Qualityof recovery from surgery and anesthesia
QoR 15K questionairre
Time to first flatus
gas out time pointsyes or no

Full Information

First Posted
March 7, 2023
Last Updated
August 19, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05773950
Brief Title
Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant as PONV Prevention
Official Title
Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

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

5. Study Description

Brief Summary
As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.
Detailed Description
Intervention Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg, Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures, Laparoscopy
Keywords
PONV, fosaprepitant, dexamethasone, palonosetron

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual therapy group
Arm Type
Placebo Comparator
Arm Description
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes. The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
Arm Title
Triple therapy group
Arm Type
Experimental
Arm Description
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes. The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
Intervention Type
Drug
Intervention Name(s)
fosaprepitant
Other Intervention Name(s)
emend
Intervention Description
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. In the experimental group, the subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
placebo
Intervention Description
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.
Primary Outcome Measure Information:
Title
the incidence of Postoperative nausea and vomiting
Description
yes or no
Time Frame
during 24 hours after surgery
Secondary Outcome Measure Information:
Title
the incidence of Postoperative nausea and vomiting
Description
yes or no
Time Frame
during post-anesthesia care unit stay, during 6 hours after surgery
Title
the severity of Postoperative nausea and vomiting
Description
numeric rating scale 0-10 and PONV impact scale
Time Frame
during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
Title
rescue antiemetics
Description
dose
Time Frame
during 24 hours after surgery
Title
time to rescue antiemetics
Description
the first administration time point of rescue antiemetics
Time Frame
during 24 hours after surgery
Title
postoperative pain at rest and couging
Description
numeric rating scale 0-10
Time Frame
during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
Title
opioid consumption
Description
morphine equivalent dose
Time Frame
during 24 hours after surgery
Title
Any adverse event
Description
yes or no
Time Frame
during 24 hours after surgery
Title
Time to normal diet
Description
time of succes of normal diet
Time Frame
during 24 hours after surgery
Title
Qualityof recovery from surgery and anesthesia
Description
QoR 15K questionairre
Time Frame
during 24 hours after surgery
Title
Time to first flatus
Description
gas out time pointsyes or no
Time Frame
during in hospital stay, an average of 5 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing laparoscopic gynecological surgery. Adults between the ages of 18 and 50 American Society of Anesthesiologists Physical Status (ASA physical status I, II Exclusion Criteria: American Association of Anesthesiologists physical standards (ASA physical status III or higher) Children under the age of 19 Adults over 49 years of age Diabetes Mellitus Pregnant or lactating women Patients with a history of allergy or contraindications for use of the study drug Patients who did not understand this study or expressed their refusal. Patients with a history of serious psychologic disease that may affect the patient evaluation Patients taking serotonergic drugs
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

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Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant as PONV Prevention

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