Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-05-30

Brief Summary

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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

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Detailed Description

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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

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Remazolam Anesthesia Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Remazolam

Intervention Type DRUG

sedation

Remifentanil

Intervention Type DRUG

2ug/kg Remifentanil

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.

Group Type ACTIVE_COMPARATOR

ciprofol

Intervention Type DRUG

sedation

Remifentanil

Intervention Type DRUG

2ug/kg Remifentanil

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

Group Type ACTIVE_COMPARATOR

Remazolam

Intervention Type DRUG

sedation

Flumazenil

Intervention Type DRUG

antagonism

Remifentanil

Intervention Type DRUG

2ug/kg Remifentanil

Interventions

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ciprofol

sedation

Intervention Type DRUG

Remazolam

sedation

Intervention Type DRUG

Flumazenil

antagonism

Intervention Type DRUG

Remifentanil

2ug/kg Remifentanil

Intervention Type DRUG

Other Intervention Names

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haisco pharmaceutical group Yichang Humanwell Pharmaceutical Company Enwa Pharmaceutical Company Yichang Humanwell Yichang Humanwell Pharmaceutical Company

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No