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A Phase IIb Clinical Study of Isoflurane Injection

A Phase IIb, Randomized, Double Blind, Parallel-group, Active-controlled, Multicenter Study of Isoflurane Injection-To assess the efficacfy and safety of isoflurane injection for induction of general anesthesia in patients undergonging selective operation and compared it with propofol.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16007924
Enrollment
Unknown
Registered
2016-02-15
Start date
2016-02-22
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 general anesthesia

Interventions

Control group (Propofol):The subjects received a bolus IV injection of 2 mg propofol
Experimental group (isoflurane injection):The subjects received a bolus IV injection of 20 mg/kg isoflurane injection

Sponsors

Yichang HumanWell Pharmaceutical Co.,Ltd
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. 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;

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
MOAA/S;

Secondary

MeasureTime frame
BIS;eyelash reflex;Intubation reaction;success rate of intubaion;

Countries

China

Contacts

Public ContactZhang Wensheng
zhangws@vip.163.com+86 18980601564

Outcome results

None listed

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