RecruitingNCT07294989

The Effective Blood Concentration of Ciprofol

Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study


Sponsor

Peking University Shenzhen Hospital

Enrollment

101 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

1. Eligible patients were selected and enrolled in the study. 2. General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction. 3. The patients' pain and cognition are followed up after surgery.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • Patients aged 18-65 years
  • Scheduled for elective thyroidectomy
  • ASA physical status classification I-II
  • Willing to participate and providing written informed consent

Exclusion Criteria6

  • Recent use of sedatives or opioid analgesics
  • Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance \<35 mL/min ,Requiring preoperative dialysis
  • Significant cardiovascular comorbidities
  • Body mass index ≥35 kg/m² or \<18.5 kg/m²
  • Known hypersensitivity or adverse reactions to propofol/ciprofol
  • Neuropsychiatric disorders including:Alzheimer's disease,History of cerebrovascular events,Traumatic brain injury,Space-occupying brain lesions,Other significant neurological deficits

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Interventions

DRUGCiprofol

Beginning with an initial target plasma concentration of ciprofol at 1.2 μg/mL. Assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and Bispectral Index (BIS) values are performed every minute until the patient achieves a complete anesthetic state (defined as an MOAA/S score of 0).


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07294989


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