Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

NCT06205719 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2023-234-1
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

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

Conditions

Remazolam Anesthesia; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• time for recovery

  The time from stopping the anesthetic to waking up

  3 second to 30minutes

Study Arms (3)

Remazolam combined with Remifentanil anesthesia

EXPERIMENTAL

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

ciprofol combined with Remifentanil anesthesia

ACTIVE COMPARATOR

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

The flumazenil was injected at the end of the surgery

ACTIVE COMPARATOR

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

ciprofol DRUG

sedation

Also known as: haisco pharmaceutical group

ciprofol combined with Remifentanil anesthesia

Remazolam DRUG

sedation

Also known as: Yichang Humanwell Pharmaceutical Company

Remazolam combined with Remifentanil anesthesia; The flumazenil was injected at the end of the surgery

Flumazenil DRUG

antagonism

Also known as: Enwa Pharmaceutical Company

The flumazenil was injected at the end of the surgery

Remifentanil DRUG

2ug/kg Remifentanil

Also known as: Yichang Humanwell Yichang Humanwell Pharmaceutical Company

Remazolam combined with Remifentanil anesthesia; The flumazenil was injected at the end of the surgery; ciprofol combined with Remifentanil anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with known or suspected genetic susceptibility to malignant hyperthermia;
• Patients with history of asthma;
• Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs;
• Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs;
• Patients with history of psychotropic drug abuse within 3 months;
• Patients with long-term alcohol abuse;
• People with mental disorder and unable to communicate normally;

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Flumazenil; Remifentanil

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ting Xu

  Sichuan provincial Peopel'Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YanYu Liu

CONTACT

13438348895; 43197113@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 16, 2024
• Study Start: June 1, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 20, 2024

Record last verified: 2024-05