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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06241131
Other study ID # 2023-501
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date September 30, 2025

Study information

Verified date January 2024
Source Sichuan Provincial People's Hospital
Contact Zhang
Phone 13882705707
Email giggle5707@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 220
Est. completion date September 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sichuan Provincial People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery time The length of time from stopping anesthesia to patient recovery (opening eyes) up to 1 hour
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