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Not yet recruitingNCT06205719Updated May 20, 2024

Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

An Early Phase 1 interventional study of ciprofol and Remazolam in Remazolam Anesthesia and Postoperative Recovery, sponsored by Sichuan Provincial People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-20.

Sponsored by Sichuan Provincial People's Hospital · Early Phase 1, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Remazolam Anesthesia
  • Postoperative Recovery
03

In context

Lead sponsor

Sichuan Provincial People's Hospital is the lead sponsor of 76 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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;
05

Study design

Phase
Early Phase 1
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
93 participants (estimated)

Study arms

  • Experimental
    Remazolam combined with Remifentanil anesthesia

    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.

    Drug: Remazolam · Drug: Remifentanil

  • Active comparator
    ciprofol combined with Remifentanil anesthesia

    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.

    Drug: ciprofol · Drug: Remifentanil

  • Active comparator
    The flumazenil was injected at the end of the surgery

    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

    Drug: Remazolam · Drug: Flumazenil · Drug: Remifentanil

Interventions

  • Drugciprofol

    sedation

    Also known as: haisco pharmaceutical group

  • DrugRemazolam

    sedation

    Also known as: Yichang Humanwell Pharmaceutical Company

  • DrugFlumazenil

    antagonism

    Also known as: Enwa Pharmaceutical Company

  • DrugRemifentanil

    2ug/kg Remifentanil

    Also known as: Yichang Humanwell Yichang Humanwell Pharmaceutical Company

06

What researchers measure

Primary outcomes

  1. time for recovery

    The time from stopping the anesthetic to waking up

    Time frame: 3 second to 30minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06205719
Lead sponsor
Sichuan Provincial People's Hospital
Responsible party
Ting Xu (Principal Investigator, Sichuan Provincial People's Hospital) — Principal investigator
First posted
Jan 16, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
May 30, 2025 (estimated)
Completion
May 30, 2026 (estimated)
Last update
May 20, 2024

Study contacts

YanYu Liu
Contact
43197113@qq.com
13438348895
Ting Xu
principal investigator · Sichuan provincial Peopel'Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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