ClinicalTrials.gg
RecruitingNCT07294989Updated Jan 6, 2026

The Effective Blood Concentration of Ciprofol

An observational study in Thyroid Disease, sponsored by Peking University Shenzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Peking University Shenzhen Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
101
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Thyroid Disease

Browse trials for

03

In context

Thyroid Diseases

365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.

This study's planned enrollment of 101 is below the median of 198 across 158 observational studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Peking University Shenzhen Hospital is the lead sponsor of 17 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Recent use of sedatives or opioid analgesics
  • Severe hepatic or renal dysfunction defined as: class C (score ≥10), \<35 mL/min ,Requiring preoperative dialysis
  • Significant cardiovascular comorbidities
  • ≥35 kg/m² or \<18.5 kg/m²
  • Known 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
101 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • ciprofol group

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

    Drug: Ciprofol

Interventions

  • 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).

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What researchers measure

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;)

    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 outcomes

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

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

  2. Bispectral index

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

    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.

  3. The EC₅₀ and EC₉₅ of ciprofol

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

  4. Heart rate

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

    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.

  5. Blood pressure

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

    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.

07

Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 29027770 ↗
  • Rosow C, Manberg PJ. Bispectral index monitoring. Anesthesiol Clin North Am. 2001 Dec;19(4):947-66, xi. doi: 10.1016/s0889-8537(01)80018-3. PubMed 11778388 ↗
  • Guo X, Qiao Y, Yin S, Luo F, Yi L, Chen J, Lu M. Pharmacokinetics and pharmacodynamics of ciprofol after continuous infusion in elderly patients. BMC Anesthesiol. 2025 Jan 27;25(1):41. doi: 10.1186/s12871-025-02907-4. PubMed 39871139 ↗
  • Liu L, Wang K, Yang Y, Hu M, Chen M, Liu X, Yan P, Wu N, Xiang X. Population pharmacokinetic/pharmacodynamic modeling and exposure-response analysis of ciprofol in the induction and maintenance of general anesthesia in patients undergoing elective surgery: A prospective dose optimization study. J Clin Anesth. 2024 Feb;92:111317. doi: 10.1016/j.jclinane.2023.111317. Epub 2023 Nov 15. PubMed 37976683 ↗
  • Irwin MG, Hui TW, Milne SE, Kenny GN. Propofol effective concentration 50 and its relationship to bispectral index. Anaesthesia. 2002 Mar;57(3):242-8. doi: 10.1046/j.0003-2409.2001.02446.x. PubMed 11879213 ↗
  • Kateliya R, Madhukant, Dubey M, Chandra S, Sahay N. Comparison of recovery profiles in target-controlled infusions (TCI) versus manually controlled infusions for total intravenous anesthesia (TIVA) in laparoscopic surgeries. A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2023 Apr-Jun;39(2):258-263. doi: 10.4103/joacp.joacp_396_21. Epub 2023 Apr 19. PubMed 37564857 ↗
  • Mu J, Jiang T, Xu XB, Yuen VM, Irwin MG. Comparison of target-controlled infusion and manual infusion for propofol anaesthesia in children. Br J Anaesth. 2018 May;120(5):1049-1055. doi: 10.1016/j.bja.2017.11.102. Epub 2018 Feb 3. PubMed 29661382 ↗
  • Hu C, Horstman DJ, Shafer SL. Variability of target-controlled infusion is less than the variability after bolus injection. Anesthesiology. 2005 Mar;102(3):639-45. doi: 10.1097/00000542-200503000-00024. PubMed 15731604 ↗
  • Russell D, Wilkes MP, Hunter SC, Glen JB, Hutton P, Kenny GN. Manual compared with target-controlled infusion of propofol. Br J Anaesth. 1995 Nov;75(5):562-6. doi: 10.1093/bja/75.5.562. PubMed 7577281 ↗
  • Nimmo AF, Absalom AR, Bagshaw O, Biswas A, Cook TM, Costello A, Grimes S, Mulvey D, Shinde S, Whitehouse T, Wiles MD. Guidelines for the safe practice of total intravenous anaesthesia (TIVA): Joint Guidelines from the Association of Anaesthetists and the Society for Intravenous Anaesthesia. Anaesthesia. 2019 Feb;74(2):211-224. doi: 10.1111/anae.14428. Epub 2018 Oct 31. PubMed 30378102 ↗
  • Perez-Otal B, Aragon-Benedi C, Pascual-Bellosta A, Ortega-Lucea S, Martinez-Ubieto J, Ramirez-Rodriguez JM; Research Group in Anaesthesia, Resuscitation, and Perioperative Medicine of Institute for Health Research Aragon (ISS Aragon). Neuromonitoring depth of anesthesia and its association with postoperative delirium. Sci Rep. 2022 Jul 26;12(1):12703. doi: 10.1038/s41598-022-16466-y. PubMed 35882875 ↗
  • Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51. PubMed 2286697 ↗
  • Daccache N, Wu Y, Jeffries SD, Zako J, Harutyunyan R, Pelletier ED, Laferriere-Langlois P, Hemmerling TM. Safety and recovery profile of patients after inhalational anaesthesia versus target-controlled or manual total intravenous anaesthesia: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2025 May;134(5):1474-1485. doi: 10.1016/j.bja.2025.02.007. Epub 2025 Mar 11. PubMed 40074622 ↗
  • Yang D, Zhou J, Sun L, Li M, Zhang J. Comparison of postoperative awakening between ciprofol and propofol in elderly patients undergoing hip replacement surgery: a single-blind, randomized, controlled trial. Minerva Anestesiol. 2024 Dec;90(12):1074-1081. doi: 10.23736/S0375-9393.24.18263-6. Epub 2024 Dec 3. PubMed 39625705 ↗
  • Chen L, Xie Y, Du X, Qin W, Huang L, Dai J, Qin K, Huang J. The Effect of Different Doses of Ciprofol in Patients with Painless Gastrointestinal Endoscopy. Drug Des Devel Ther. 2023 Jun 12;17:1733-1740. doi: 10.2147/DDDT.S414166. eCollection 2023. PubMed 37333965 ↗
  • Li J, Wang X, Liu J, Wang X, Li X, Wang Y, Ouyang W, Li J, Yao S, Zhu Z, Guo Q, Yu Y, Meng J, Zuo Y. Comparison of ciprofol (HSK3486) versus propofol for the induction of deep sedation during gastroscopy and colonoscopy procedures: A multi-centre, non-inferiority, randomized, controlled phase 3 clinical trial. Basic Clin Pharmacol Toxicol. 2022 Aug;131(2):138-148. doi: 10.1111/bcpt.13761. Epub 2022 Jun 10. PubMed 35653554 ↗
  • Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8. PubMed 34116176 ↗
  • Teng Y, Ou MC, Wang X, Zhang WS, Liu X, Liang Y, Zuo YX, Zhu T, Liu B, Liu J. Pharmacokinetic and pharmacodynamic properties of ciprofol emulsion in Chinese subjects: a single center, open-label, single-arm dose-escalation phase 1 study. Am J Transl Res. 2021 Dec 15;13(12):13791-13802. eCollection 2021. PubMed 35035718 ↗
  • Hu C, Ou X, Teng Y, Shu S, Wang Y, Zhu X, Kang Y, Miao J. Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial. Adv Ther. 2021 Nov;38(11):5484-5500. doi: 10.1007/s12325-021-01914-4. Epub 2021 Sep 24. PubMed 34559359 ↗
  • Liao J, Li M, Huang C, Yu Y, Chen Y, Gan J, Xiao J, Xiang G, Ding X, Jiang R, Li P, Yang M. Pharmacodynamics and Pharmacokinetics of HSK3486, a Novel 2,6-Disubstituted Phenol Derivative as a General Anesthetic. Front Pharmacol. 2022 Feb 3;13:830791. doi: 10.3389/fphar.2022.830791. eCollection 2022. PubMed 35185584 ↗
  • de Gasperi A, Mazza E, Noe L, Corti A, Cristalli A, Prosperi M, Sabbadini D, Savi MC, Vai S. Pharmacokinetic profile of the induction dose of propofol in chronic renal failure patients undergoing renal transplantation. Minerva Anestesiol. 1996 Jan-Feb;62(1-2):25-31. PubMed 8768021 ↗
  • Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3. PubMed 32415708 ↗
  • Petkar S, Bele A, Priya V, Bawiskar D. Pharmacological Insights and Clinical Applications of Ciprofol: A Narrative Review. Cureus. 2024 Aug 28;16(8):e68034. doi: 10.7759/cureus.68034. eCollection 2024 Aug. PubMed 39347129 ↗
  • Curro JM, Santonocito C, Merola F, Messina S, Sanfilippo M, Brancati S, Drago F, Sanfilippo F. Ciprofol as compared to propofol for sedation and general anesthesia: a systematic review of randomized controlled trials. J Anesth Analg Crit Care. 2024 Apr 8;4(1):24. doi: 10.1186/s44158-024-00159-1. PubMed 38589912 ↗
  • He KQ, Huang TT, Tan MY, Gao C, Wang S. Efficacy and Safety of Ciprofol Versus Propofol as Anesthetic for Patients Undergoing Painless Colonoscopy. Pain Ther. 2024 Dec;13(6):1633-1644. doi: 10.1007/s40122-024-00662-x. Epub 2024 Oct 14. PubMed 39400664 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.

Of 69 non-industry observational studies under Thyroid Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 203. This study's planned 11 months is below that.

Counting every sponsor, half of 74 studies reached it within 30 months; a quarter within 12 and three quarters within 203.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2025
First posted
Dec 19, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jun 30, 2026
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07294989
Lead sponsor
Peking University Shenzhen Hospital
Responsible party
Sponsor
First posted
Dec 19, 2025
Start date
Jul 1, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jan 6, 2026

Study contacts

Tao Luo
Contact
496855048@qq.com
+86 135 1082 0779

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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