Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

Postoperative Recovery Clinical Trial

Official title:

Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery-A Single-center, Prospective, Randomized, Double-blind, Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205719
• Other study ID #: 2023-234-1
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 20, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: January 2024
• Source: Sichuan Provincial People's Hospital
• Contact: YanYu Liu
• Phone: 13438348895
• Email: 43197113[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 93
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Postoperative Recovery

Intervention

Drug:
• ciprofol
sedation
• Remazolam
sedation
• Flumazenil
antagonism
• Remifentanil
2ug/kg Remifentanil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for recovery	The time from stopping the anesthetic to waking up	3 second to 30minutes