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Clinical application of remimazolam besylate in postoperative recovery quality of major spinal surgery

Clinical application of remimazolam besylate in postoperative recovery quality of major spinal surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092451
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

major spine surgery

Interventions

the Remimazolam Group:Remimazolam-flumazenil

Sponsors

The Second Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old, gender is not limited, elective spine surgery (expected operation duration= 3 hours). 2. ASA classification I-III, 18Kg/?<=BMI<=30kg/?. 3. Be able to understand the procedures and methods of this trial, be willing to strictly abide by the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Difficult airway, lung infection and acute stage of asthma. 2. Patients with recent myocarditis, endocarditis, history of heart failure or recent thrombosis (= 160mmHg and/or diastolic blood pressure >=90mmHg), diabetes mellitus (random blood glucose>=11.1 mmol/L). 4. Patients who are allergic to benzodiazepines, opioids, propofol or muscle relaxants, history of epilepsy, long-term alcohol dependence, and long-term drug abuse. 5. Patients with previous mental illness or taking psychotropic drugs, history of cognitive dysfunction or impaired consciousness. 6. Abnormal liver function, AST and/or ALT >= 2.5 × upper limit of normal, TBIL >= 1.5 × upper limit of normal. 7. Abnormal renal function, urea or urea nitrogen >= 1.5× upper limit of normal, and serum creatinine higher than the upper limit of normal. 8. Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
the incidence of delayed emergence;

Secondary

MeasureTime frame
the time to obey verbal command;the time to BIS over 80 ;the time to extubation;the length of the PACU stay (PACU LOS);adverse events throughout recovery.;Richmond Agitation-Sedation Scale (RASS) scores ;Modified Aldrete scores;

Countries

China

Contacts

Public ContactRuping Dai

The Second Xiangya Hospital, Central South University

xyeyyrupingdai@csu.edu.cn+86 189 7492 4753

Outcome results

None listed

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