Adverse Effect of Intravenous Anesthetics
Conditions
Keywords
Phase I trial, Emulsified Isoflurane, Health volunteer
Brief 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.
Interventions
DRUGEmulsified Isoflurane
Sponsors
Sichuan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of emulsified isoflurane as an intravenous anesthetics | 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. |
Countries
China
Outcome results
None listed