Clinical trial

Study on the Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery-A Single Center, Prospective, Randomized, Double-blind, Controlled Clinical Trial

Name
2023-501
Description
The goal of this clinical trials to study and compare the effects of "desflurane with remifentanil anesthesia (study group)" and "sevoflurane with remifentanil anesthesia (control group)" for elective fundus surgery anesthesia. The main question it aims to answer are the characteristics of desflurane anesthesia in patients undergoing fundus surgery and to provide universal guidance for clinical application.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-30
Trial end
2025-09-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Desflurane Inhalant Product
The Desflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.
Arms:
desflurane with remifentanil anesthesia, sevoflurane with remifentanil anesthesia
Size
220
Primary endpoint
Recovery time
up to 1 hour
Eligibility criteria
Inclusion Criteria: 1. ASA I-II, patients aged 18-65 years old; 2. Fundus surgery to be performed under general anesthesia ; 3. The expected duration of surgery is about 30-120 min ; 4. BMI: 18-30 kg/m2 ; 5. Those who signed the informed consent form and volunteered to participate in this trial Exclusion Criteria: 1. Patients with known or suspected genetic susceptibility to malignant hyperthermia; 2. Patients with history of asthma; 3. Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs; 4. Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs; 5. Patients with history of psychotropic drug abuse within 3 months; 6. Patients with long-term alcohol abuse; 7. People with mental disorder and unable to communicate normally;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}
Updated at
2024-02-05

1 organization

1 product

2 indications

Product
Desflurane