Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
101 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-07-01
Study Completion Date
2026-06-30
Brief Summary
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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.
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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Detailed Description
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Conditions
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Thyroid Disease
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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ciprofol group
Anesthesia induction was achieved through target-controlled infusion of ciprofol.
Ciprofol
Intervention Type
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).
Interventions
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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).
Intervention Type
DRUG
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking University Shenzhen Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
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RESULT
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.
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RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
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2025-117
Identifier Type: -
Identifier Source: org_study_id
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