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

Sponsor

Samsung Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05773950

Collaborator

(none)

144

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting Gynecologic Surgical Procedures Laparoscopy	Drug: fosaprepitant Drug: normal saline	N/A

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,

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized placebo-controlled trialRandomized placebo-controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Dual therapy group 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.	Drug: normal saline 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. Other Names: placebo
Experimental: Triple therapy group 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.	Drug: fosaprepitant 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. Other Names: emend

Arm

Intervention/Treatment

Placebo Comparator: Dual therapy group

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.

Drug: normal saline

Other Names:

placebo

Experimental: Triple therapy group

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.

Drug: fosaprepitant

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.

Other Names:

emend

Outcome Measures

Primary Outcome Measures

the incidence of Postoperative nausea and vomiting [during 24 hours after surgery]
yes or no

Secondary Outcome Measures

the incidence of Postoperative nausea and vomiting [during post-anesthesia care unit stay, during 6 hours after surgery]
yes or no
the severity of Postoperative nausea and vomiting [during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery]
numeric rating scale 0-10 and PONV impact scale
rescue antiemetics [during 24 hours after surgery]
dose
time to rescue antiemetics [during 24 hours after surgery]
the first administration time point of rescue antiemetics
postoperative pain at rest and couging [during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery]
numeric rating scale 0-10
opioid consumption [during 24 hours after surgery]
morphine equivalent dose
Any adverse event [during 24 hours after surgery]
yes or no
Time to normal diet [during 24 hours after surgery]
time of succes of normal diet
Qualityof recovery from surgery and anesthesia [during 24 hours after surgery]
QoR 15K questionairre
Time to first flatus [during in hospital stay, an average of 5 days]
gas out time pointsyes or no

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts 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