- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998165
A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised
November 13, 2015 updated by: Janssen Pharmaceutical K.K.
An Open-Label Study to Evaluate the Efficacy and Safety of JNJ-268229 in Pediatric Subjects General Anesthetised
The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.
Study Overview
Detailed Description
This is multicenter, open-label (identity of assigned study drug will be known) one-arm study in pediatric participants receiving general anesthesia.
The participants are children aged 1-15 years old, planned to undergo head and neck, thoracic (except heart), urological, orthopedic or plastic surgery.
Approximately 80 participants will be enrolled in this study.
These participants are divided into two groups by age (1-6 and 7-15 years old).
Pharmacokinetic (what the body does to the drug,) blood samples will be collected from at least 3 participants between the ages of 1 and 6 years and at least 3 participants between the ages of 7 and 15 years from 15 minutes after the start of infusion to the end of infusion of the study drug .
The study consists of 4 phases: screening phase, treatment phase, recovery phase and follow-up phase.
Screening for eligible participants will be performed within 14 days before administration of the study drug.
The safety and tolerability of study drug will be evaluated by physical examinations, electrocardiogram (ECG), clinical laboratory tests, vital signs, and adverse events (AEs) according to the Time and Events Schedule.
Participants safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Asahikawa, Japan
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Kobe, Japan
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Kure, Japan
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Kurume, Japan
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Ohmura, Japan
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Osaka, Japan
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Shimajiri, Japan
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Shimotsuke, Japan
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants scheduled to receive surgery under general anesthesia, necessitating airway securing with tracheal intubation and analgesia with opioid analgesics
- American Society of Anesthesiologists (ASA) Physical Status Classification is I or II at the time of operation planning
- Participants scheduled to receive operations estimated to take 30 minutes or more from skin incision i.e. Head and neck, thoracic (except heart), intraperitoneal, ophthalmological, otorhinolaryngological, urological, orthopedic or plastic surgery
- Girls having undergone menarche are eligible only if the urine pregnancy test at the time of screening is negative Exclusion Criteria:-
- Chronic use of opioid analgesics or their use within 12 hours before the planned start of general anesthesia - Hypersensitivity to opioid analgesics or local anesthetics
- History of jaundice or unexplained fever induced by halogenated anesthetics
- Unstable hemodynamics (eg. congenital heart disease, congenital diaphragmatic hernia) Ideal body weight is not within the 10th to 90th percentile received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study drug or is currently enrolled in an investigational study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Remifentanil (0.25 µg/kg/min)
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After intubation, continuous intravenous infusion of remifentanil (0.25 µg/kg/min) is started, while anesthesia is maintained with inhaled or intravenous anesthetics.
In cases where sedation by general anesthetics and analgesia by lidocaine does not seem to provide a sufficient means of analgesia at the time of intubation, remifentanil may be used, beginning before intubation.
The rate of infusion may be adjusted while monitoring the subject's general condition in 25% to 100% increments or in 25% to 50% decrements every 2 to 5 minutes, but should not exceed 1.3 µg/kg/min.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with positive response to skin incision
Time Frame: 5-minute assessment period after skin incision
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Positive response is defined by the presence of at least one of below listed conditions: Heart rate increased >20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for >1 minute); Systolic blood pressure increased >20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for >1 minute; Gross movement, swallowing, eye opening (if there are patches on the eyes, this assessment might be not evaluated) or grimacing and sweating, lachrymation or mydriasis.
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5-minute assessment period after skin incision
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodynamics stability
Time Frame: 5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Heart Rate and Blood Pressure increased >20% above baseline that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision for less than or equal to 1 minute.
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5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Drugs used to deal with insufficient anesthesia (inadequate anesthesia) or excessive anesthesia
Time Frame: Time interval between completion of anesthesia and extubation
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The time interval between completion of anesthesia and extubation is calculated based on both the time upon completion of general anesthesia and the time upon completion of extubation and recorded.
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Time interval between completion of anesthesia and extubation
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Assessment on analgesic effect
Time Frame: 240 minutes after completion of anesthesia
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Assess an analgesic effect of JNJ-268229 during operation on 3-point ranging from "effective / not effective / undeterminable" generally.
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240 minutes after completion of anesthesia
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Total dose level of remifentanil
Time Frame: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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The overall use (including dose increase/decrease, time of dose increase/decrease and start time of single supplemental bolus injection, etc) of remifentanil will be recorded.
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1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Total concomitant anesthetic dose level
Time Frame: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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The overall use (drug name, dose and start time, etc) of the inhaled or intravenous anesthetics used for general anesthesia
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1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Time from completion of anesthesia to resumption of spontaneous respiration
Time Frame: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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The time taken from completion of anesthesia to resumption of spontaneous respiration is calculated based on both the time upon completion of general anesthesia and the time upon confirmation of resumed spontaneous respiration and recorded.
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1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Time until arrival of Steward Postanesthetic Recovery Score at 6
Time Frame: 240 minutes after completion of anesthesia or skin closure
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Recovery Score is rated as Consciousness,Airway and Movement
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240 minutes after completion of anesthesia or skin closure
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Time from completion of anesthesia to discharge from the recovery room
Time Frame: 240 minutes after completion of anesthesia or skin closure
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Anesthesia is calculated based on both the time upon completion of general anesthesia and the time upon discharge from the operating /recovery room.
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240 minutes after completion of anesthesia or skin closure
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Respiratory stability
Time Frame: 5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Heart Rate and Blood Pressure increased >20% above baseline that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision for less than or equal to 1 minute.
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5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
November 15, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimate)
November 28, 2013
Study Record Updates
Last Update Posted (Estimate)
November 16, 2015
Last Update Submitted That Met QC Criteria
November 13, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR102524
- ULTIVAANS3001 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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