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Phase I Trial of Emulsified Isoflurane

This study has been completed.
Sponsor:
Information provided by:
Sichuan University
ClinicalTrials.gov Identifier:
NCT01302353
First received: February 23, 2011
Last updated: NA
Last verified: February 2010
History: No changes posted

February 23, 2011
February 23, 2011
May 2010
September 2010   (final data collection date for primary outcome measure)
Vital Signs [ Time Frame: after drug infusion to 24 hours after infusion ] [ Designated as safety issue: Yes ]

The vital signs include heart rate, cardiac rhythm, blood pressure, respiratory rate, pulse oxygen saturation, body temperature and end-tidal carbon dioxide.

All the parameters are measured at the following time points:

  1. before drug infusion, recorded as baseline;
  2. every one minute, immediately from drug infusion to 15 min after infusion;
  3. every two minutes, from 15 min to 30 min after infusion;
  4. every five minutes, from 30 min to 60 min afeter infusion;
  5. every one hour, from 1 hour to 4 hours after infusion;
  6. 8 hours and 24 hours after infusion.
Same as current
No Changes Posted
Efficacy of emulsified isoflurane as an intravenous anesthetics [ Time Frame: immediate from drug infusion, up to 24 hours after infusion ] [ Designated as safety issue: No ]

This secondary outcome is an observational one only.

The response to verbal command, to pain stimulus; and eyelash reflex are tested.

The orientation and finger-to-nose test are also tested.

The end-tidal partial pressure of isoflurane, observer's assessment of alertness/sedation (modified OAS/S score) and Bispectral index (BIS) are also recored.
Same as current
Not Provided
Not Provided
 
Phase I Trial of Emulsified Isoflurane
Phase I Trial of Emulsified Isoflurane in Adult Healthy Volunteers

In this trial, our primary goal is to investigate the safety of intravenous infusion of emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop severe adverse event in any dose group or any volunteer develop fatal adverse event in any group.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adverse Effect of Intravenous Anesthetics
Drug: Emulsified Isoflurane
  • Experimental: Arm 1 (0.0024 ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 2 (0.006ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.006ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 3 (0.012ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.012ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 4 (0.02ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.02ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 5 (0.0301ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0301ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 6 (0.0391ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0391ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 7 (0.0508ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0508ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 8 (0.066ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.066ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 9 (0.0859ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0859ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 10 (0.1116ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1116ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 11 (0.1451ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1451ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 12 (0.1886ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1886ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 13 (0.2452ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.2452ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 14 (0.3188ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.3188ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 15 (0.4144ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.4144ml/kg.
    Intervention: Drug: Emulsified Isoflurane
  • Experimental: Arm 16 (0.5387ml/kg)
    In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.5387ml/kg.
    Intervention: Drug: Emulsified Isoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18~45 years old (50:50 male:female) healthy volunteer;
  • Body Mass Index (BMI) 19~24;

  • health volunteers assessed by medical history and physical examination

    • systolic blood pressure between 100~140mmHg;
    • heart rate between 60~100bpm;
    • pulse oxygen saturation > 97% when inspiring air and reaching 100% after inspiring 100% oxygen for 5 min;
    • with normal result for routine lab test, including complete blood count, chemical test, urine test and stool test;
  • Non-smoker and no history of alcohol or drug abuse;
  • Fully understand the whole process of this trial and sign the informed consent.

Exclusion Criteria:

  • Any history of allergy, especially to isoflurane or intralipid;
  • Any suspected history of malignant hyperthermia in the volunteer or his/her relatives;
  • Recent use of a medication with a pronounced effect on the central nervous system or any other organ (within 3 month)
  • Recent participation in other clinical trial (within 1 month)
  • Any history of difficult airway or suspected difficult airway;
  • Pregnancy;
  • Hyperlipidemia.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01302353
PITEI, 2009L01628
Yes
Dr. Jin Liu, Department of Anesthesiology, West China Hospital, Sichuan University
Sichuan University
Not Provided
Principal Investigator: Jin Liu, M.D Department of Anesthesiology, West China Hospital, Sichuan University
Sichuan University
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP