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

January 26, 2024 updated by: Ting Xu, Sichuan Provincial People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: desflurane with remifentanil anesthesia
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
The Desflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.
Active Comparator: sevoflurane with remifentanil anesthesia
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
The Desflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: up to 1 hour
The length of time from stopping anesthesia to patient recovery (opening eyes)
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Investigators

  • Study Chair: Ting Xu, MD, Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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