The Effective Blood Concentration of Ciprofol

NCT07294989 | Recruiting DMC

• 1 other identifier: 2025-117
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Disease

Outcome Measures

Primary Outcomes (1)

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

  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；)

  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).

Secondary Outcomes (5)

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

  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).

• Bispectral index

  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.

• The EC₅₀ and EC₉₅ of ciprofol

  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).

• Heart rate

  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.

• Blood pressure

  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.

Study Arms (1)

ciprofol group

Anesthesia induction was achieved through target-controlled infusion of ciprofol.

Drug: Ciprofol

Interventions

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).

ciprofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Thyroid Diseases

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Central Study Contacts

Tao Luo

CONTACT

+86 135 1082 0779; 496855048@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: December 19, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-06

Locations

CN (1)