A Phase IIc Clinical Study of Isoflurane Injection

A Phase IIc Clinical Study of Isoflurane Injection -Single-center, randomized controlled study of pharmacokinetics and pharmacodynamics of inhaled isoflurane and isoflurane injection

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17012142

Enrollment

Unknown

Registered

2017-07-26

Start date

2017-07-31

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of general anesthesia

Interventions

Isoflurane Injection:Isoflurane Injection

inhaled Isoflurane:inhaled Isoflurane

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Patient must be be able to consent and complete the required assessments and procedures; 2. Patients aged 18-45 years, BMI19-24; 3. American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P2; 4. operation time =< 3 h except operation of cardiothoracic surgery and neurosurgery; 5. Laboratory and imaging findings were normal or abnormal but no clinical significance.

Exclusion criteria

Exclusion criteria: 1. Any history of allergy, especially to isoflurane or lipid emulsion;Any suspected history of malignant hyperthermia in the volunteer or his/her relatives; 2. Pregnancy or having pregnancy plan within 1 month and lactation; 3. systolic pressure140 mmHg;heart rate120 bpm; 4. QT/QTc interval excessive prolongation(male>470 msfemal>480 ms); 5. Cognitive dysfunction, Disorientation check failed and the accuracy of Finger-Naseversch <80%; 6. Known or expected difficult airway or suspected difficult airway; 7. History of alcohol, drugs, or medication abuse; 8. Patient has participated in an investigational drug study within 3 month prior to study start. Participate the study again; 9. the sponsor and investigators or their relatives; 10. the investigator think the patient should be excluded for any reason.

Design outcomes

Primary

Measure	Time frame
BIS;isoflurane concentration of venous blood;isoflurane concentration of artery blood;Inhalation of isoflurane concentration;Exhalation of isoflurane concentration;blood pressure;heart rate;electrocardiogram;SpO2;SpO2;liver function;renal function;glucose;electrolyte;temperature;CO2;other safety index;	—

Countries

China

Contacts

Public ContactZhang Weiyi

Department of Anesthesiology, West China Hospital, Sichuan University

1370461@qq.com+86 18980601837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026