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Clinical Trials/NCT07294989
NCT07294989RecruitingNot Applicable

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

Peking University Shenzhen Hospital1 site in 1 country101 target enrollmentStarted: July 1, 2025Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
101
Locations
1
Primary Endpoint
The effect-site concentration of cipofol, when MOAAS reaches 2
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

ciprofol group

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

Intervention: Ciprofol (Drug)

Outcomes

Primary Outcomes

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

  • 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.)

Investigators

Sponsor
Peking University Shenzhen Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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