Phase I Trial of Emulsified Isoflurane

Sichuan University78 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adverse Effect of Intravenous Anesthetics

Interventions

Emulsified IsofluraneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Vital Signs

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.

Time frame: after drug infusion to 24 hours after infusion

Secondary Outcomes

Efficacy of emulsified isoflurane as an intravenous anesthetics

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.

Time frame: immediate from drug infusion, up to 24 hours after infusion

Data from ClinicalTrials.gov

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