A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised

NCT01998165 | Completed Phase 3

• 2 other identifiers: CR102524ULTIVAANS3001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Anesthesia

Keywords

Anesthesia; Remifentanil; Ultiva

Outcome Measures

Primary Outcomes (1)

• Number of participants with positive response to skin incision

  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.

  5-minute assessment period after skin incision

Secondary Outcomes (9)

• Hemodynamics stability

  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

• Drugs used to deal with insufficient anesthesia (inadequate anesthesia) or excessive anesthesia

  Time interval between completion of anesthesia and extubation

• Assessment on analgesic effect

  240 minutes after completion of anesthesia

• Total dose level of remifentanil

  1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

• Total concomitant anesthetic dose level

  1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure

Study Arms (1)

Remifentanil (0.25 µg/kg/min)

EXPERIMENTAL

Drug: Remifentanil

Interventions

Remifentanil DRUG

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.

Also known as: remifentanil hydrochloride (JNJ-268229)

Remifentanil (0.25 µg/kg/min)

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (9)

Unknown Facility

Asahikawa, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kure, Japan

Location

Unknown Facility

Kurume, Japan

Location

Unknown Facility

Ohmura, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Shimajiri, Japan

Location

Unknown Facility

Shimotsuke, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Links

• An Open-Label Study to Evaluate the Efficacy and Safety of JNJ-268229 in Pediatric Subjects General Anesthetised

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

JP (9)