Desflurane AnesthesiaEarly Phase 1NCT06241131
The Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery
A Early Phase 1 study testing Desflurane Inhalant Product in people with Desflurane Anesthesia and Postoperative Recovery, run by Sichuan Provincial People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Desflurane Anesthesia, Postoperative Recovery
- What is being tested?
- Desflurane Inhalant Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Desflurane Anesthesia, Postoperative Recovery
- Being tested
- Desflurane Inhalant Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane Inhalant ProductDrug
The Desflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Desflurane Inhalant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
The length of time from stopping anesthesia to patient recovery (opening eyes)
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desflurane AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Xu, Sichuan Provincial People's Hospital
- Investigators
- Ting Xu, MD, Study chair, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241131
- Sponsor's protocol ID
- 2023-501
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery-A Single Center, Prospective, Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06241131
- Acronym / sponsor ID
- 2023-501
- Conditions
- Desflurane Anesthesia, Postoperative Recovery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desflurane with remifentanil anesthesia | Experimental | Drug: Desflurane Inhalant ProductSubjects 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. |
| sevoflurane with remifentanil anesthesia | Active comparator | Drug: Desflurane Inhalant ProductSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desflurane Inhalant ProductThe Desflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously. | Drug | desflurane with remifentanil anesthesia, sevoflurane with remifentanil anesthesia |
Primary outcome
Recovery time
Time frame: up to 1 hour
The length of time from stopping anesthesia to patient recovery (opening eyes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Xu, MD study chair
Sichuan Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Desflurane Inhalant Product in people with Desflurane Anesthesia and Postoperative Recovery, run by Sichuan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang (13882705707, giggle5707@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.