Analgesia
Conditions
Brief summary
This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing. The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
Interventions
DRUGRemifentanil
Basically there is no treatment allocation. Subjects who would be administered of remifentanil at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients requiring general anesthesia
Exclusion criteria
* According to precautions or warnings on PI, remifentanil should not be administered to the following patients * Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Unexpected Serious Adverse Event | 24 hours | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event | 24 hours | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record. |
| Number of Participants With a Serious Adverse Event | 24 hours | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record. |
| Number of Participants With the Indicated Unexpected Adverse Event | 24 hours | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings. |
Participant flow
Recruitment details
The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Ultiva in the real clinical setting after launch.
Participants by arm
| Arm | Count |
|---|---|
| Ultiva 1, 2, or 3 mg One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision. | 766 |
| Total | 766 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 9 |
Baseline characteristics
| Characteristic | Ultiva 1, 2, or 3 mg |
|---|---|
| Age, Continuous | 45.3 Years STANDARD_DEVIATION 16.5 |
| Race/Ethnicity, Customized Korean | 766 participants |
| Race/Ethnicity, Customized Not Korean | 0 participants |
| Sex/Gender, Customized Female | 422 Participants |
| Sex/Gender, Customized Male | 343 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 187 / 766 |
| serious Total, serious adverse events | 0 / 766 |
Outcome results
Primary
Number of Participants With an Unexpected Serious Adverse Event
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.
Time frame: 24 hours
Population: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultiva 1, 2, or 3 mg | Number of Participants With an Unexpected Serious Adverse Event | Participants with unexpected SAEs | 0 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With an Unexpected Serious Adverse Event | Participants with no unexpected SAEs | 766 participants |
Secondary
Number of Participants With an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record.
Time frame: 24 hours
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultiva 1, 2, or 3 mg | Number of Participants With an Adverse Event | 187 participants |
Secondary
Number of Participants With a Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record.
Time frame: 24 hours
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultiva 1, 2, or 3 mg | Number of Participants With a Serious Adverse Event | 0 participants |
Secondary
Number of Participants With the Indicated Unexpected Adverse Event
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.
Time frame: 24 hours
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Dizziness | 1 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Chest discomfort | 1 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Dyspepsia | 1 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Headache | 1 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Dysuria | 1 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Coughing | 1 participants |
| Ultiva 1, 2, or 3 mg | Number of Participants With the Indicated Unexpected Adverse Event | Premature ventricular contraction | 1 participants |