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Phase I Trial of Emulsified Isoflurane

NCT01302353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2011-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Adverse Effect of Intravenous Anesthetics

Interventions

DRUG

Emulsified Isoflurane

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • Jin Liu, M.D · Department of Anesthesiology, West China Hospital, Sichuan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302353 on ClinicalTrials.gov