Patients who require at least 6 hours or more mechanical ventilation under intensive care and require analgesics.
Conditions
Interventions
investigational material(s)
Generic name etc : Remifentanil Hydrochloride
INN of investigational material : Remifentanil Hydrochloride
Therapeutic category code : 821 Synthetic narcotics
Dosage and Ad
Sponsors
Maruishi Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 years or older (at the time of signing informed consent). 2) Patients or his/her legal representative providing written informed consent for study participation in person. 3) Patients who is expected to require more than 6 hrs and less than 10 days of respiratory management with intubation under intensive care and are anticipated to require pain relief. 4) Patients who need postoperative ICU management: ASA I to III at the post-operative diagnosis. 5) If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.
Exclusion criteria
Exclusion criteria: 1) Patients with severe damage on the central nervous system. 2) Patients who are judged by investigator or sub-investigator to have a neurological disease that will make pain/sedation assessment difficult. 3) Patients who are contraindicated to opioid analgesics, or patients who are suspected to cause allergic reactions to concomitant medications during the study period. 4) Patients with any history of hypersensitivities to fentanyl products or to any of the ingredients of the study drug 5) Patients who received Nalmefene hydrochloride hydrate within 1 week prior to the study drug administration, or patients who expected to receive Nalmefene hydrochloride hydrate during the study drug administration. 6) Patients who require local anesthetic, epidural or intrathecal administration of analgesics, or nerve block. 7) Patients with contraindicated to muscle relaxant. 8) Patients who likely to cause respiratory depression, such as coma due to head injury or brain tumor. 9) Patients with history of seizure. 10) Patients with asthma. 11) Patients with concurrent or previous drug abuse. 12) Patients with concurrent or previous alcoholism. 13) Patients with a history of severe drug hypersensitivity. 14) Patients who received treatment with any study drug or medical device in a clinical study within 4 months prior to the informed consent procedure, or who are planning to participate in another clinical study before the end of this study. 15) Patients who received treatment with any study drug in a clinical research within 4 months prior to the informed consent procedure, or who are planning to participate in another clinical research before the end of this study. 16) Patients who judged serious status, which may cause death within 24 hours. 17) Patients who are not able to comply with all procedures prescribed in the protocol. 18) Patients with massive bleeding and are considered reoperation. 19) In the Investigators or subinvestigators opinion, patients who are assessed inappropriate to participate this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy efficacy / Percentage of patients who did not require rescue administration of analgesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics safety efficacy / 1) Number of doses and total dosage of rescue analgesics. 2) Dosage of analgesics during the study drug administration period. 3) Percentage of time spent BPS <=5 or NRS <=3 4) Percentage of time spent RASS <=0 5) Percentage of time spent RASS -2 to 0 6) Time until the end of mechanical ventilation after the end of study drug administration. 7) Time until the end of mechanical ventilation after the start of tapering, 8) Infusion rate of the study drug and duration of the administration. safety / 1) Adverse events 2) Laboratory values 3) Vital signs (Blood pressure, heart rate, respiratory rate) and SpO2, ETCO2 4) Blood gas 5) ECG monitoring pharmacokinetics/ Blood concentration of Remifentanil | — |
Countries
Japan
Outcome results
None listed