Phase I Trial of Emulsified Isoflurane

February 23, 2011 updated by: Sichuan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Institute of Drug Clinical Trial• GCP Center,West China Hospital, Sichuan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital Signs
Time Frame: after drug infusion to 24 hours after infusion

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.
after drug infusion to 24 hours after infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of emulsified isoflurane as an intravenous anesthetics
Time Frame: immediate from drug infusion, up to 24 hours after infusion

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.
immediate from drug infusion, up to 24 hours after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jin Liu, M.D, Department of Anesthesiology, West China Hospital, Sichuan University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PITEI
  • 2009L01628 (Other Identifier: State Food and Drug Administration of P.R. China)

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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