Phase I Trial of Emulsified Isoflurane
This study has been completed.
Sponsor:
Sichuan University
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
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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:
- before drug infusion, recorded as baseline;
- every one minute, immediately from drug infusion to 15 min after infusion;
- every two minutes, from 15 min to 30 min after infusion;
- every five minutes, from 30 min to 60 min afeter infusion;
- every one hour, from 1 hour to 4 hours after infusion;
- 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
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, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013