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Phase IIa Trial of Isoflurane injection

the dose finding of isoflurane injection combined with fentanyl and midazolam during the induction

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCS-13004773
Enrollment
Unknown
Registered
2013-09-22
Start date
2014-06-10
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Induction of anesthesia

Interventions

different does of isoflurane injection groups:isoflurane injection

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patient must be be able to consent and complete the required assessments and procedures; 2. Patients aged 18-65 years; 3. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P2; 4. operation time =< 3 hexcept operation of cardiothoracic surgery and neurosurgery; 5. laboratory examination results are normal or abnormal but without 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

MeasureTime frame
score of MOAA/S;blood pressure;heart rate;electrocardiogram;SpO2;

Secondary

MeasureTime frame
BIS;eyelash reflex;Intubation reaction;reaction to painful stimulation;

Countries

China

Contacts

Public ContactZhang Wensheng

Anestheology department of West China Hospital, Sichuan University

1370461@qq.com+86 18980601564

Outcome results

None listed

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