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Median effective dose (ED50) of remimazolam for high-intensity focused ultrasound ablation: A double-blind, prospective trial

Median effective dose (ED50) of remimazolam for high-intensity focused ultrasound ablation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084538
Enrollment
Unknown
Registered
2024-05-20
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Uterine fibroids, uterine adenomyomas

Interventions

Remimazolam group:Double-blind method was used in the study. All patients were forbidden to drink for 2 hours and fast for 8 hours before surgery, and no preoperative medication was given. Open periph

Sponsors

Guangzhou Women and Children's Medical Center Liuzhou Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients with uterine fibroids or adenomyomas undergoing elective surgery with Haifu knife, aged 18-55 years, ASAI-II grade, BMI18.5-28.5.

Exclusion criteria

Exclusion criteria: ? There are contraindications for the treatment of HiFu; ?Known allergy or hypersensitivity to the investigational drug; ? With heart, brain, lung, liver, kidney and hematopoietic system and other vital organ dysfunction: ? Patients with uncontrolled hypertension, uncontrolled hyperthyroidism, and severe anemia; ? Those who have cognitive dysfunction and other mental system diseases are unable to cooperate.

Design outcomes

Primary

MeasureTime frame
Sedative effect;bispectral index,BIS;

Secondary

MeasureTime frame
Operation time;Duration of anesthesia;Recovery time;Sufentanil dosage;Remazolam dosage;Number of cases requiring additional sufentanil analgesia;The number of cases where arousal failed due to excessive sedation;The number of adverse events that occurred;Intraoperative awareness (whether amnesia occurs);Postoperative complication;Blood pressure;Heart rate;Pulse oxygen saturation;Respiratory rate;Patient satisfaction;Doctor satisfaction;Analgesic effect;Whether the operation was successful or not;

Countries

China

Contacts

Public ContactWei Anna

Guangzhou Women and Children's Medical Center Liuzhou Hospital

918774072@qq.com+86 199 7825 1058

Outcome results

None listed

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