Phase I Trial of Emulsified Isoflurane

Sichuan University

Status and phase: Completed; Phase 1

Conditions: Adverse Effect of Intravenous Anesthetics

Treatments: Drug: Emulsified Isoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01302353

2009L01628 (Other Identifier)

PITEI

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 16 patient groups

Arm 1 (0.0024 ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 2 (0.006ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 3 (0.012ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 4 (0.02ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 5 (0.0301ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 6 (0.0391ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 7 (0.0508ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 8 (0.066ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 9 (0.0859ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 10 (0.1116ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 11 (0.1451ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 12 (0.1886ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 13 (0.2452ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 14 (0.3188ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 15 (0.4144ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane

Arm 16 (0.5387ml/kg)

Experimental group

Description:

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

Treatment:

Drug: Emulsified Isoflurane