Adverse Effect of Intravenous AnestheticsPhase 1NCT01302353
Phase I Trial of Emulsified Isoflurane
A Phase 1 study testing Emulsified Isoflurane in people with Adverse Effect of Intravenous Anesthetics, run by Sichuan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Intravenous Anesthetics
- What is being tested?
- Emulsified Isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Drug Clinical Trial• GCP Center,West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: 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.
- Being tested
- Emulsified Isoflurane
- Keywords
- Phase I trial, Emulsified Isoflurane, Health volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emulsified IsofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (0.0024 ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 2 (0.006ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.006ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 3 (0.012ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.012ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 4 (0.02ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.02ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 5 (0.0301ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0301ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 6 (0.0391ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0391ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 7 (0.0508ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0508ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 8 (0.066ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.066ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 9 (0.0859ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0859ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 10 (0.1116ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1116ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 11 (0.1451ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1451ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 12 (0.1886ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1886ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 13 (0.2452ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.2452ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 14 (0.3188ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.3188ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 15 (0.4144ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.4144ml/kg. Receives: Drug: Emulsified Isoflurane |
| Arm 16 (0.5387ml/kg) | Experimental | In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.5387ml/kg. Receives: Drug: Emulsified Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: after drug infusion to 24 hours after infusion
Secondary outcomes (1)
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.
Measured: immediate from drug infusion, up to 24 hours after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Intravenous AnestheticsStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Investigators
- Jin Liu, M.D, Principal investigator, Department of Anesthesiology, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302353
- Sponsor's protocol ID
- PITEI
- Other IDs
- 2009L01628
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Emulsified Isoflurane in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01302353
- Acronym / sponsor ID
- PITEI
- Keywords
- Phase I trial, Emulsified Isoflurane, Health volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (0.0024 ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg. |
| Arm 2 (0.006ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.006ml/kg. |
| Arm 3 (0.012ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.012ml/kg. |
| Arm 4 (0.02ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.02ml/kg. |
| Arm 5 (0.0301ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0301ml/kg. |
| Arm 6 (0.0391ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0391ml/kg. |
| Arm 7 (0.0508ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0508ml/kg. |
| Arm 8 (0.066ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.066ml/kg. |
| Arm 9 (0.0859ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0859ml/kg. |
| Arm 10 (0.1116ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1116ml/kg. |
| Arm 11 (0.1451ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1451ml/kg. |
| Arm 12 (0.1886ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1886ml/kg. |
| Arm 13 (0.2452ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.2452ml/kg. |
| Arm 14 (0.3188ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.3188ml/kg. |
| Arm 15 (0.4144ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.4144ml/kg. |
| Arm 16 (0.5387ml/kg) | Experimental | Drug: Emulsified IsofluraneIn this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.5387ml/kg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
- Non-smoker and no history of alcohol or drug abuse;
- Fully understand the whole process of this trial and sign the informed consent.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emulsified Isoflurane | Drug | Arm 1 (0.0024 ml/kg), Arm 10 (0.1116ml/kg), Arm 11 (0.1451ml/kg), Arm 12 (0.1886ml/kg), Arm 13 (0.2452ml/kg), Arm 14 (0.3188ml/kg), Arm 15 (0.4144ml/kg), Arm 16 (0.5387ml/kg), Arm 2 (0.006ml/kg), Arm 3 (0.012ml/kg), Arm 4 (0.02ml/kg), Arm 5 (0.0301ml/kg), Arm 6 (0.0391ml/kg), Arm 7 (0.0508ml/kg), Arm 8 (0.066ml/kg), Arm 9 (0.0859ml/kg) |
Primary outcome
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.
1 secondary outcome
Efficacy of emulsified isoflurane as an intravenous anesthetics
Time frame: immediate from drug infusion, up to 24 hours after infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)
Hypospadias, Anesthesia; Adverse Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Liu, M.D principal investigator
Department of Anesthesiology, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emulsified Isoflurane in people with Adverse Effect of Intravenous Anesthetics, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Signs (time frame: after drug infusion to 24 hours after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.