The Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery

NCT06241131 | Unknown Early Phase 1

• 1 other identifier: 2023-501
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Desflurane Anesthesia; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Recovery time

  The length of time from stopping anesthesia to patient recovery (opening eyes)

  up to 1 hour

Study Arms (2)

desflurane with remifentanil anesthesia

EXPERIMENTAL

Subjects were randomly assigned to the experimental group。In this group, desflurane was inhaled at a starting concentration of 1 MAC (Minimal Alveolar Concentration), and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.

Drug: Desflurane Inhalant Product

sevoflurane with remifentanil anesthesia

ACTIVE COMPARATOR

Subjects were randomly assigned to the active comparator group。In this group, sevoflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.

Drug: Desflurane Inhalant Product

Interventions

Desflurane Inhalant Product DRUG

The Desflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.

desflurane with remifentanil anesthesia; sevoflurane with remifentanil anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II, patients aged 18-65 years old;
• Fundus surgery to be performed under general anesthesia ;
• The expected duration of surgery is about 30-120 min ;
• BMI: 18-30 kg/m2 ;
• Those who signed the informed consent form and volunteered to participate in this trial

You may not qualify if:

• Patients with known or suspected genetic susceptibility to malignant hyperthermia;
• Patients with history of asthma;
• Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs;
• Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs;
• Patients with history of psychotropic drug abuse within 3 months;
• Patients with long-term alcohol abuse;
• People with mental disorder and unable to communicate normally;

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Officials

• Ting Xu, MD

  Sichuan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Zhang

CONTACT

13882705707; giggle5707@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: February 5, 2024
• Study Start: March 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: September 30, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share