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Safety and efficacy of repeated remimazolam tosilate sedation in patients receiving interstitial brachytherapy for cervical cancer and its impact on sleep quality

Safety and efficacy of repeated remimazolam tosilate sedation in patients receiving interstitial brachytherapy for cervical cancer and its impact on sleep quality

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108294
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Patients with cervical cancer undergoing interstitial brachytherapy

Interventions

Group remimazolam:Sufentanil 0.1 µg/kg + granisetron 3mg+remimazolam [induction: 0.3 mg/kg, maintenance: 0.2-1 mg/kg/h]
Group propofol:Sufentanil 0.1 µg/kg + granisetron 3mg+ propofol [induction 1.5 mg/kg, maintenance: 2-6 mg/kg/h (0-1 µg/kg/min)]

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)Histologically confirmed cervical carcinoma candidates for three interstitial brachytherapy sessions (2)BMI 18-30 kg/m^2 (3)ASA class I-II (4) Provision of signed informed consent and willingness to comply with follow-up evaluations.

Exclusion criteria

Exclusion criteria: (1) Patients declining trial participation; (2) History of severe cardiac, cerebral, pulmonary, hepatic, renal, or metabolic diseases; (3) Previous adverse anesthesia recovery; (4) Electrocardiogram (ECG) showing heart rate 180 mmHg and/or diastolic BP >110 mmHg) or hypotension (7 one day pre-procedure.

Design outcomes

Primary

MeasureTime frame
Intraoperative adverse effects;

Secondary

MeasureTime frame
hypoxemia; hypotension;bradycardia;SpO2;Blood pressure;Heart rate;Operation time;Awakening time;Total sedative drugs;Postoperative adverse effects;Pittsburgh Sleep Quality Index;Athens Insomnia Scale;

Countries

China

Contacts

Public ContactShu Jinjun

Sichuan Cancer Hospital

shuhu918@163.com+86 135 5020 7607

Outcome results

None listed

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