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The Efficiency and Safety of Remimazolam and Propofol for Patients-Controlled Sedative Application Combined with Target-Controlled Remifentanil Injection in Transvenous Leads Extraction Surgery: A Randomized, Single-blinded, Parallel-controlled Trial

The Efficiency and Safety of Remimazolam and Propofol for Patients-Controlled Sedative Application Combined with Target-Controlled Remifentanil Injection in Transvenous Leads Extraction Surgery: A Randomized, Single-blinded, Parallel-controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050668
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Transvenous Leads Extraction

Interventions

Experimental group1:Using remimazolam for sedation
Experimental group2:Using propofol for sedation

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who underwent electrode removal of cardiac implanted electronic devices in Peking University People's Hospital from September 2021 to June 2022; 2. Use local anesthesia assisted by sedation and analgesia; 3. The informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1. Past history of sedative drug and alcohol abuse; 2. Obvious difficult airway or obesity (BMI>30) during preoperative visit; 3. Have sleep apnea syndrome; 4. Patients with special electrodes such as ICD, CRT, CRT-D, etc.; 5. The anesthesia method may be selected or may be changed midway due to the condition; 6. The patient's mental state cannot be tested for subjective assessment; 7. Patients who cannot perform radial artery puncture to measure invasive pressure; 8. Aged 80 years; 9. Unable to correctly understand the use of self-controlled pumps.

Design outcomes

Primary

MeasureTime frame
bispectral index;

Secondary

MeasureTime frame
modified observer’s assessment of alert score;heart rate;blood pressure;peripheral arterial oxygen saturation;respiratory rate;

Countries

China

Contacts

Public ContactJiang Luyang

Peking University People's Hospital

jiangly1018@hotmail.com+86 13269054309

Outcome results

None listed

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