Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

Early Phase 1

Not yet recruiting

• Conditions: Remazolam Anesthesia; Postoperative Recovery
• Interventions: Drug: Remazolam; Drug: ciprofol; Drug: Remifentanil; Drug: Flumazenil

• Registration Number: NCT06205719
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief 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

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 Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Study Start: 2024-06-01
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 93

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remazolam combined with Remifentanil anesthesia	Remazolam	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 flumazenil was injected at the end of the surgery	Remazolam	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
Remazolam combined with Remifentanil anesthesia	Remifentanil	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.
ciprofol combined with Remifentanil anesthesia	ciprofol	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.
ciprofol combined with Remifentanil anesthesia	Remifentanil	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.
The flumazenil was injected at the end of the surgery	Flumazenil	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
The flumazenil was injected at the end of the surgery	Remifentanil	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

Primary Outcome Measures

Name	Time	Method
time for recovery	3 second to 30minutes	The time from stopping the anesthetic to waking up