Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

S

Sichuan Provincial People's Hospital

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Remazolam Anesthesia
Postoperative Recovery

Treatments

Drug: Remifentanil
Drug: Flumazenil
Drug: ciprofol
Drug: Remazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT06205719
2023-234-1

Details and patient eligibility

About

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

Full 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

Enrollment

93 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

  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;

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

93 participants in 3 patient groups

Remazolam combined with Remifentanil anesthesia
Experimental group
Description:
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.
Treatment:
Drug: Remazolam
Drug: Remifentanil
ciprofol combined with Remifentanil anesthesia
Active Comparator group
Description:
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.
Treatment:
Drug: Remifentanil
Drug: ciprofol
The flumazenil was injected at the end of the surgery
Active Comparator group
Description:
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
Treatment:
Drug: Remazolam
Drug: Remifentanil
Drug: Flumazenil

Trial contacts and locations

0

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Central trial contact

YanYu Liu

Data sourced from clinicaltrials.gov

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