Phase I Trial of Emulsified Isoflurane

NCT ID: NCT01302353

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-09-30

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.

Conditions

Adverse Effect of Intravenous Anesthetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 (0.0024 ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 2 (0.006ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.006ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 3 (0.012ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.012ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 4 (0.02ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.02ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 5 (0.0301ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0301ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 6 (0.0391ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0391ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 7 (0.0508ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0508ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 8 (0.066ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.066ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 9 (0.0859ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0859ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 10 (0.1116ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1116ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 11 (0.1451ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1451ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 12 (0.1886ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1886ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 13 (0.2452ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.2452ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 14 (0.3188ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.3188ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 15 (0.4144ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.4144ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Arm 16 (0.5387ml/kg)

In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.5387ml/kg.

Group Type: EXPERIMENTAL

Emulsified Isoflurane

Intervention Type: DRUG

Interventions

Emulsified Isoflurane

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Department of Anesthesiology, West China Hospital, Sichuan University

Principal Investigators

Jin Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, West China Hospital, Sichuan University

Locations

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

Chengdu, Sichuan, China

Countries

China

Other Identifiers

2009L01628

Identifier Type: OTHER

Identifier Source: secondary_id

PITEI

Identifier Type: -

Identifier Source: org_study_id