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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
  Purpose

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.


Condition Intervention Phase
Adverse Effect of Intravenous Anesthetics
Drug: Emulsified Isoflurane
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Emulsified Isoflurane in Adult Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Sichuan University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 78
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 (0.0024 ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Drug: Emulsified Isoflurane

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302353

Locations
China, Sichuan
Institute of Drug Clinical Trial• GCP Center,West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Sichuan University
Investigators
Principal Investigator: Jin Liu, M.D Department of Anesthesiology, West China Hospital, Sichuan University
  More Information

No publications provided

Responsible Party: Dr. Jin Liu, Department of Anesthesiology, West China Hospital, Sichuan University
ClinicalTrials.gov Identifier: NCT01302353     History of Changes
Other Study ID Numbers: PITEI, 2009L01628
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sichuan University:
Phase I trial
Emulsified Isoflurane
Health volunteer

Additional relevant MeSH terms:
Isoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014