Remazolam AnesthesiaEarly Phase 1NCT06205719
Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery
A Early Phase 1 study testing ciprofol, Remazolam and Flumazenil in people with Remazolam Anesthesia and Postoperative Recovery, run by Sichuan Provincial People's Hospital.
Trial summary
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Remazolam Anesthesia, Postoperative Recovery
- What is being tested?
- ciprofol, Remazolam and Flumazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 May 2026
- 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: Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery-A Single-center, Prospective, Randomized, Double-blind, Controlled Clinical Trial
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery
Read the detailed description
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery。There are three groups.In Group H, ciprofol + Remifentanil was used for maintenance of anesthesia, in Group R, remifentanil + Remifentanil was used for maintenance of anesthesia, in Group RF, remifentanil + Remifentanil was used for maintenance of anesthesia, at the end of the operation, flumazenil was used to counteract the residual anesthetic effect.The quality of postoperative recovery was compared
- Conditions
- Remazolam Anesthesia, Postoperative Recovery
- Being tested
- ciprofol, Remazolam, Flumazenil, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
Also called haisco pharmaceutical group
sedation
RemazolamDrug
Also called Yichang Humanwell Pharmaceutical Company
sedation
FlumazenilDrug
Also called Enwa Pharmaceutical Company
antagonism
RemifentanilDrug
Also called Yichang Humanwell Yichang Humanwell Pharmaceutical Company
2ug/kg Remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Remazolam combined with Remifentanil anesthesia | Experimental | 0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. Receives: Drug: Remazolam; Drug: Remifentanil |
| ciprofol combined with Remifentanil anesthesia | Active comparator | 0.4mg/kg ciprpfol and 2ug/kg Remifentanil for induction of anesthesia,remifentanil 0.1 μg/kg/min and 0.4-2.4mg/kg/h ciprpfol were continuously pumped intravenously. Receives: Drug: ciprofol; Drug: Remifentanil |
| The flumazenil was injected at the end of the surgery | Active comparator | 0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. The 0.5mg flumazenil was injected at the end of the surgery Receives: Drug: Remazolam; Drug: Flumazenil; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for recovery
The time from stopping the anesthetic to waking up
Measured: 3 second to 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remazolam 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
- 93 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, Principal investigator, Sichuan provincial Peopel'Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205719
- Sponsor's protocol ID
- 2023-234-1
- Status last verified
- May 2024
- First submitted
- 2 Jan 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery-A Single-center, Prospective, Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06205719
- Acronym / sponsor ID
- 2023-234-1
- Conditions
- Remazolam Anesthesia, Postoperative Recovery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 16 Jan 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.
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery
Detailed description
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery。There are three groups.In Group H, ciprofol + Remifentanil was used for maintenance of anesthesia, in Group R, remifentanil + Remifentanil was used for maintenance of anesthesia, in Group RF, remifentanil + Remifentanil was used for maintenance of anesthesia, at the end of the operation, flumazenil was used to counteract the residual anesthetic effect.The quality of postoperative recovery was compared
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remazolam combined with Remifentanil anesthesia | Experimental | Drug: Remazolam, Drug: Remifentanil0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. |
| ciprofol combined with Remifentanil anesthesia | Active comparator | Drug: ciprofol, Drug: Remifentanil0.4mg/kg ciprpfol and 2ug/kg Remifentanil for induction of anesthesia,remifentanil 0.1 μg/kg/min and 0.4-2.4mg/kg/h ciprpfol were continuously pumped intravenously. |
| The flumazenil was injected at the end of the surgery | Active comparator | Drug: Remazolam, Drug: Flumazenil, Drug: Remifentanil0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. The 0.5mg flumazenil was injected at the end of the surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 ;
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 |
|---|---|---|
| ciprofolAlso: haisco pharmaceutical groupsedation | Drug | ciprofol combined with Remifentanil anesthesia |
| RemazolamAlso: Yichang Humanwell Pharmaceutical Companysedation | Drug | Remazolam combined with Remifentanil anesthesia, The flumazenil was injected at the end of the surgery |
| FlumazenilAlso: Enwa Pharmaceutical Companyantagonism | Drug | The flumazenil was injected at the end of the surgery |
| RemifentanilAlso: Yichang Humanwell Yichang Humanwell Pharmaceutical Company2ug/kg Remifentanil | Drug | Remazolam combined with Remifentanil anesthesia, The flumazenil was injected at the end of the surgery, ciprofol combined with Remifentanil anesthesia |
Primary outcome
time for recovery
Time frame: 3 second to 30minutes
The time from stopping the anesthetic to waking up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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 principal investigator
Sichuan provincial Peopel'Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ciprofol, Remazolam and Flumazenil in people with Remazolam 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 6 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 20 May 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 YanYu Liu (13438348895, 43197113@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time for recovery (time frame: 3 second to 30minutes). 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 20 May 2024.