Thoracic Surgery
Conditions
Interventions
Experimental Group:Patients receive 16 mg of Ondansetron Orally Dissolving Film within 2 hours before anesthesia induction. Additionally, patients receive 8 mg of Ondansetron Orally Dissolving Film at
Control Group :Patients receive 16 mg of placebo orally dissolving film within 2 hours before anesthesia induction.
Additionally, patients receive 8 mg of placebo orally dissolving film at 4 ± 0.5 hou
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)No gender restriction, age between 18 and 80 years (18 <= age < 80). (2)Patients scheduled for pulmonary-related surgery. (3)Patients assessed to have at least 2 high-risk factors for postoperative nausea and vomiting (PONV). (4)The subject, authorized representative, or legal guardian has been informed of the nature of the study, understands the protocol requirements, can ensure compliance, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with a history of allergic reactions to ondansetron. (2)Patients who are pregnant or breastfeeding. (3)Patients who may not comply with the study protocol (including the follow-up period), such as those with psychiatric disorders or drug abuse. (4)Patients expected to undergo non-laparoscopic surgery. (5)Any other conditions deemed by the investigator as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of nausea and/or vomiting within the acute phase (within 24 hours after surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of nausea and/or vomiting within the acute phase (within 24 hours after surgery).;Incidence and occurrence of nausea and/or vomiting during the delayed phase (24-72 hours after surgery);Severity of nausea and vomiting during the delayed phase (24-72 hours after surgery): The severity of nausea and vomiting will be assessed using the PONV Visual Analog Scale (VAS). ;Patient-reported outcomes (PRO): Nausea and vomiting reported using the Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0).;Functional Living Index-Emesis (FLIE) assessment: Scores will be evaluated based on the Functional Living Index-Emesis (FLIE) questionnaire.;Incidence of adverse events and serious adverse reactions during medication use, with a focus on common antiemetic-related events such as constipation and headache.;Other evaluation metrics include: Time to first occurrence of nausea after surgery; Time to first occurrence of vomiting after surgery; Time to discontinuation of the analgesic pump; Postoperative Day 1 ambulation distance, etc.; | — |
Countries
China
Contacts
Public ContactShaHua.Ma; WanPu.Yan
Peking University Cancer Hospital
Outcome results
None listed