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Clinical application of remimazolam-sevoflurane balanced anesthesia on postoperative recovery in major spine surgery

Clinical application of remimazolam-sevoflurane balanced anesthesia on postoperative recovery in major spine surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102262
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-08-18

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 sevoflurane maintenance combined with flumazenil antagonism
The Propofol Group:propofol sevoflurane maintenance not combined with flumazenil antagonism

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 range: 18-65 years old, gender not limited, scheduled for open surgery in spinal surgery (expected anesthesia duration >= 3 hours); 2. ASA grades I-III; 3. 18Kg/m^2 <= BMI <= 30kg/m^2; 4. Can understand the procedures and methods of this trial, willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Difficult airways, pulmonary infections, and acute asthma; 2. Patients with recent history of myocarditis, endocarditis, heart failure, or recent thrombosis (= 160mmHg and/or diastolic blood pressure >= 90mmHg), diabetes (random blood glucose >= 11.1 mmol/L); 4. Individuals allergic to benzodiazepines, opioids, propofol, or muscle relaxants, with a history of epilepsy, long-term alcohol dependence, and long-term drug abuse; 5. Patients with a history of previous mental illness or use of psychotropic drugs, cognitive impairment, or consciousness disorders; 6. Abnormal liver function, AST and/or ALT >= 2.5 x upper limit of normal, TBIL >= 1.5 x upper limit of normal; 7. Abnormal renal function, urea or urea nitrogen >= 1.5 times the upper limit of normal, and blood creatinine above the upper limit of normal; 8. Expected bleeding volume is greater than 800ml; 9. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
the incidence of delayed emergence;

Secondary

MeasureTime frame
the time to emergence;Time for BIS to recover to 80;the time to obey demand;the time to extubation;PACU dwell time ;emergence agitation;QoR15;

Countries

China

Contacts

Public ContactDai Ruping

The Second Xiangya Hospital, Central South University

xyeyyrupingdai@qq.com+86 189 7492 4753

Outcome results

None listed

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