Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Recovery; Remazolam Anesthesia
• Intervention / Treatment: Drug: Remazolam; Drug: Remifentanil; Drug: ciprofol; Drug: Flumazenil

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 Type: Interventional
• Enrollment (Estimated): 93
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: YanYu Liu; Phone Number: 13438348895; Email: 43197113@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; sedation; Other Names: Yichang Humanwell Pharmaceutical Company; Drug: Remifentanil; 2ug/kg Remifentanil; Other Names: Yichang Humanwell Yichang Humanwell Pharmaceutical Company
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: Remifentanil; 2ug/kg Remifentanil; Other Names: Yichang Humanwell Yichang Humanwell Pharmaceutical Company; Drug: ciprofol; sedation; Other Names: haisco pharmaceutical group
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; sedation; Other Names: Yichang Humanwell Pharmaceutical Company; Drug: Remifentanil; 2ug/kg Remifentanil; Other Names: Yichang Humanwell Yichang Humanwell Pharmaceutical Company; Drug: Flumazenil; antagonism; Other Names: Enwa Pharmaceutical Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time for recovery	The time from stopping the anesthetic to waking up	3 second to 30minutes

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Investigators: Principal Investigator: Ting Xu, Sichuan provincial Peopel'Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Protective Agents; Analgesics, Opioid; Narcotics; GABA Modulators; GABA Agents; Antidotes; Remifentanil; Flumazenil
• Other Study ID Numbers: 2023-234-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No