Skip to content

Comparison of remimazolam Tosilate and propofol sedation on the early postoperative quality of recovery in patients undergoing day surgery

Comparison of remimazolam Tosilate and propofol sedation on the early postoperative quality of recovery in patients undergoing day surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069933
Enrollment
Unknown
Registered
2023-03-29
Start date
2023-03-24
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

day surgery

Interventions

Remimazolam group:Anesthesia induction: remiazolam 0.3 mg/kg, and anesthesia maintenance: remimazolam 1 mg/kg/h
BIS40-60 during the anesthesia period
Propofol group:Anesthesia induction: propofol 2 mg/kg, and anesthesia maintenance: propofol 4-8 mg/kg/h

Sponsors

The first People's Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1)18<= age < 65 years, gender is not limited; 2) undergoing day surgery and Anesthesia time =2h; 3) ASA I-II; 4)18kg/m2 < BMI < 30kg/m2; 5) Primary school diploma or above, able to complete the scale measurement; 6) To have a clear understanding of the study, to participate voluntarily in the study and to have their informed consent signed by them.

Exclusion criteria

Exclusion criteria: 1) Patients with moderate to severe head trauma or intracranial hypertension in the past three months; 2) Asthma, glaucoma, cardiac cerebrovascular disease, and severe liver and kidney dysfunction; 3) Preoperative diagnosis of mental neurological disorder or long-term use of psychotropic drugs, benzodiazepine, alcohol or sedatives; 4) Patients with a history of epilepsy or a family history of epilepsy; 5) A woman during pregnancy or lactation; 6) Allergic or contraindicated to any drug in the test; 7) Those who could not cooperate with MMSE and whose score was lower than the lowest score of corresponding educational level (illiterate <=17 points, primary school <=20 points, middle school <=22 points, university <=23 points) ; 8) Other conditions in which the researchers considered it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Overall recovery as assessed by PQRS on the first postoperative day;

Secondary

MeasureTime frame
The recovery in all areas of PQRS at 15 min, 40 min, 1 d and 3 d after operation;RASS scores were measured at the time of anesthesia emergence, 5 min ,15 min , and 30 min after anesthesia emergence;Extubation time;Full awake time;Use of vasoactive drugs during anesthesia;Postoperative patient and anesthesiologist satisfaction score;Other clinical adverse events;

Countries

China

Contacts

Public ContactYong Wu

Lianyungang Clinical Medical College of Nanjing Medical University

18961325621@163.com+86 189 6132 5621

Outcome results

None listed

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