An exploratory randomized controlled trial on the clinical application of remimazolam tosilate for injection in patients undergoing general anesthesia during outpatient surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048904

Enrollment

Unknown

Registered

2021-07-19

Start date

2021-10-01

Completion date

Unknown

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1:Remazolam Tosilate

Group 2:Propofol

Group 3:Remazolam Tosilate + Flumazenil

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18-75 years, no gender restrictions; 2. Perform outpatient surgery (including but not limited to ENT surgery, gynecological surgery, urological surgery, plastic surgery) and require general anesthesia; 3. Voluntarily sign or be able to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to benzodiazepines, opioids and any components of this product; 2. Participated in drug clinical trials as subjects within the past 3 months; 3. Pregnancy, lactation, possible pregnancy and planned pregnancy; 4. Other situations in which the investigator considers it inappropriate to participate in this trial.

Design outcomes

Primary

Measure	Time frame
Anesthesia induction time;Anesthesia recovery time;	—

Secondary

Measure	Time frame
Cognitive function;Postoperative delirium;The postoperative recovery scale scores;The pain scores;Peripheral venous hematology inflammatory immune composite index;Incidence of adverse events and adverse reactions;	—

Countries

China

Contacts

Public ContactMiao Changhong

Zhongshan Hospital Fudan University

miaochangh@163.com+86 13681975062

Outcome results