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A self-controlled trial of remimazolam and propofol for sedation in cervical cancer patients during interstitial brachytherapy

A self-controlled trial of remimazolam and propofol for sedation in cervical cancer patients during interstitial brachytherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065938
Enrollment
Unknown
Registered
2022-11-18
Start date
2022-11-21
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Cervical cancer implantation radiotherapy anesthesia

Interventions

Group propofol:propofol 1.5 mg/kg
Group remimazolam 1:remimazolam 0.2 mg/kg
Group remimazolam 2:remimazolam 0.3 mg/kg

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Cervical cancer patients who plan to undergo 3 interstitial brachytherapy; 2. Aged 40-65 years; 3. Weight 50-70 kg; 4. American Society of Anesthesiologists (ASA) grade I-II.

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to participate in the trial; 2. Those with a history of severe heart, brain, lung, liver, kidney and metabolic diseases; 3. Those who have a history of abnormal surgical anesthesia recovery in the past; 4. ECG prompt: heart rate 180 mmHg and/or diastolic blood pressure > 110 mmHg in patients with preoperative hypertension, or < 90/60 mmHg in patients with hypotension; 7. Those who have neuromuscular diseases and mental diseases; 8. Anemia patients; 9. Suspected abuse of narcotic analgesics or sedatives; 10. Those who are predicted to have or have had difficult airway; 11. Those who are known to be allergic to emulsions, benzodiazepines, and opioids; 12. Those who do not cooperate and cannot communicate.

Design outcomes

Primary

MeasureTime frame
blood pressure;heart rate;SpO2;Incidence of hypotension;Incidence of hypoxemia;the onset time of sedation;wake up time;

Secondary

MeasureTime frame
Nacrotrend index;observer's assessment of alertness/sedation (OAA/S) score;Injection pain;Intraoperative anesthesia effect;Other related complications;

Countries

China

Contacts

Public ContactJinjun Shu

Sichuan Cancer Hospital

shujinjun@scszlyy.org.cn+86 13550207607

Outcome results

None listed

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