None listed
Conditions
Interventions
None listed
Sponsors
Daiichi-Sankyo Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 19 years of age 2. A patient who is scheduled for surgery under anesthesia and falls under American Society of Anesthesiologists Physical Status classification 1 or 2* * Physical status classification (American Society of Anesthesiologists Physical Status classification, ASA PS classification) - Class 1: A healthy patient (nonsmoking, no or minimal alcohol use) - Class 2: A patient with mild disease [Mild diseases without actual functional limitations. Examples include smoker, drinker, pregnant woman, person with a body mass index (BMI) of exceed 30, but less 40 and patient with mild lung disease] 3. A patient who is scheduled to be or has been administered Nasea® Injection at least once in routine clinical practice setting at the medical discretion of investigator (treating physician) 4. Consent on the use of information by the patient or his/her legally authorized representative
Exclusion criteria
Exclusion criteria: 1. A patient who has a history of drug abuse or hypersensitivity to the study drug 2. A pregnant or lactating woman 3. A patient determined to be ineligible for participation in this study at the discretion of investigator (treating physician) for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of nausea and vomiting during 48 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of nausea and vomiting by time (0-6 hours / 6-24 hours / 24-48 hours) after surgery, assessed by investigator;Severity of nausea by time (0-6 hours / 6-24 hours / 24-48 hours) after surgery, assessed by subject;Number of nausea and vomiting occurrences by time (0-6 hours / 6-24 hours / 24-48 hours) after surgery;Number of additional administrations of an antiemetic during 48 hours after surgery;Safety evaluation up to 48 hours after surgery (adverse events);Incidence rate of nausea and vomiting by time (0-6 hours / 6-24 hours / 24-48 hours) after surgery according to the risk factor of PONV;Incidence rate of nausea and vomiting by time (0-6 hours / 6-24 hours / 24-48 hours) after surgery according to types of surgery and anesthesia;Incidence rate of nausea and vomiting by time (0-6 hours / 6-24 hours / 24-48 hours) after surgery according to the dosage of Nasea® Injection;Severity and number of nausea and vomiting occurrences up to 48 hours after surgery according to the use of PCA;Severity and number of nausea and vomiting occurrences up to 48 hours after surgery according to the dosage of Nasea® Injection | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hoon Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed