Recruiting NCT07294989
The Effective Blood Concentration of Ciprofol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ciprofol.
- Who it may be relevant to
- Registry conditions: Thyroid Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study
Overview
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.
Interventions
- Drug Ciprofol
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 outcome measures
- 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).]
Secondary outcome measures (5)
- 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).]
- 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.]
- 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).]
- 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.]
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Shenzhen Hospital — Shenzhen
Publications
- Glen JB. The development of 'Diprifusor': a TCI system for propofol. Anaesthesia. 1998 Apr;53 Suppl 1:13-21. doi: 10.1111/j.1365-2044.1998.53s115.x. PMID 9640110
- Shafer SL, Gregg KM. Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump. J Pharmacokinet Biopharm. 1992 Apr;20(2):147-69. doi: 10.1007/BF01070999. PMID 1629794
- Absalom AR, Glen JI, Zwart GJ, Schnider TW, Struys MM. Target-Controlled Infusion: A Mature Technology. Anesth Analg. 2016 Jan;122(1):70-8. doi: 10.1213/ANE.0000000000001009. PMID 26516798
- Zbinden AM, Maggiorini M, Petersen-Felix S, Lauber R, Thomson DA, Minder CE. Anesthetic depth defined using multiple noxious stimuli during isoflurane/oxygen anesthesia. I. Motor reactions. Anesthesiology. 1994 Feb;80(2):253-60. doi: 10.1097/00000542-199402000-00004. PMID 8311307
- Smith C, McEwan AI, Jhaveri R, Wilkinson M, Goodman D, Smith LR, Canada AT, Glass PS. The interaction of fentanyl on the Cp50 of propofol for loss of consciousness and skin incision. Anesthesiology. 1994 Oct;81(4):820-8; discussion 26A. PMID 7943832
- Eger EI 2nd, Saidman LJ, Brandstater B. Minimum alveolar anesthetic concentration: a standard of anesthetic potency. Anesthesiology. 1965 Nov-Dec;26(6):756-63. doi: 10.1097/00000542-196511000-00010. No abstract available. PMID 5844267
- Gu Y, Hao J, Wang J, Liang P, Peng X, Qin X, Zhang Y, He D. Effectiveness Assessment of Bispectral Index Monitoring Compared with Conventional Monitoring in General Anesthesia: A Systematic Review and Meta-Analysis. Anesthesiol Res Pract. 2024 Aug 7;2024:5555481. doi: 10.1155/2024/5555481. eCollection 2024. PMID 39149130
- Chiang MH, Wu SC, Hsu SW, Chin JC. Bispectral Index and non-Bispectral Index anesthetic protocols on postoperative recovery outcomes. Minerva Anestesiol. 2018 Feb;84(2):216-228. doi: 10.23736/S0375-9393.17.12033-X. Epub 2017 Oct 12. PMID 29027770
Identifiers
NCT: NCT07294989 · 2025-117