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NCT Number: NCT07294989

The Effective Blood Concentration of Ciprofol

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.

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Key information

Conditions

Thyroid Disease Endocrine System Diseases Thyroid Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

ciprofol

Drug

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).

Primary outcomes

  1. The effect-site concentration of cipofol, when MOAAS reaches 2

    Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).

    The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 2.

    (Modified Observer's Assessment of Alertness/Sedation: 5--Responds readily to name spoken in normal tone ； 4--Lethargic response to name spoken in normal tone ； 3--Responds only after name is called loudly and/or repeatedly ； 2--Responds only after mild prodding or shaking ；

    1--Responds only after painful trapezius squeeze ； 0--No response after painful trapezius squeeze；)

Secondary outcomes

  1. The effect-site concentration of cipofol, when MOAA/S reaches 0.

    Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).

    The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 0.

  2. Bispectral index

    Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values.

    Bispectral Index (BIS) values corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.

  3. The EC₅₀ and EC₉₅ of ciprofol

    Time frame: From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).

    The EC₅₀ and EC₉₅ of ciprofol corresponding to MOAA/S scores of 2 and 0

  4. Heart rate

    Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR.

    Heart rate(in bpm) corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.

  5. Blood pressure

    Time frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure.

    The systolic blood pressure, diastolic blood pressure and mean arterial pressure corresponding to different MOAAS scores were all recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Luo

CONTACT

[email protected]

+86 135 1082 0779

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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