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A randomized, single-blind, parallel and positive controlled study on the pharmacokinetics and pharmacodynamics of remimazolam besylate for induction and maintenance of general anesthesia

A randomized, single-blind, parallel and positive controlled study on the pharmacokinetics and pharmacodynamics of remimazolam besylate for induction and maintenance of general anesthesia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043698
Enrollment
Unknown
Registered
2021-02-27
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-22

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

Conditions

Anesthesia

Interventions

experimental group:Remazolam besylate for injection

Sponsors

Department of Anesthesiology, Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60, regardless of gender; 2. ASA was classified as I-III; 3. 18 kg/m2 <= BMI <= 30kg/m2; 4. Non cardiothoracic and non extracerebral surgery subjects who need elective surgery under general anesthesia and need tracheal intubation; 5. Able to understand and sign the informed consent (ICF) voluntarily, and willing to comply with the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: 1. Allergic or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone and other drugs and their components. 2. Brain injury, possible intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident and central nervous system disease; 3. Patients with mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.), long-term history of taking psychotropic drugs and cognitive impairment; 4. Taking benzodiazepines and / or opioids intermittently within one month or nearly three months; 5. There was a history of drug abuse, drug abuse and alcohol abuse in the two years before the first visit. Alcoholism was defined as drinking more than 14 times a week on a regular basis (1 time = 150 ml wine or 360 ml beer or 45 ml spirits); 6. Pregnant or lactating women; 7. Other conditions judged by the researcher not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Anesthesia induction successful;Anesthesia maintained successfully;

Secondary

MeasureTime frame
BIS value;

Countries

China

Contacts

Public ContactWang Saiying, Duan Kaiming

Department of Anesthesiology, Third Xiangya Hospital of Central South University

1771303488@qq.com+86 15874858486

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026