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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciprofol group | Anesthesia induction was achieved through target-controlled infusion of ciprofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ï¼› 4--Lethargic response to name spoken in normal tone ï¼› 3--Responds only after name is called loudly and/or repeatedly ï¼› 2--Responds only after mild prodding or shaking ï¼› 1--Responds only after painful trapezius squeeze ï¼› 0--No response after painful trapezius squeezeï¼›) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Luo | Contact | +86 135 1082 0779 | 496855048@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9640110 | Background | 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. | |
| 1629794 | 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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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
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|
| Bispectral index | Bispectral Index (BIS) values corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores. | 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 | The EC₅₀ and EC₉₅ of ciprofol corresponding to MOAA/S scores of 2 and 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). |
| Heart rate | Heart rate(in bpm) corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores. | 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 | The systolic blood pressure, diastolic blood pressure and mean arterial pressure corresponding to different MOAAS scores were all recorded. | 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. |
| 26516798 | Background | 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. |
| 8311307 | 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. |
| 7943832 | 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. |
| 5844267 | 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. |
| 39149130 | 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. |
| 29027770 | 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. |
| 11778388 | 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. |
| 39871139 | Result | 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. |
| 37976683 | 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. |
| 11879213 | 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. |
| 37564857 | 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. |
| 29661382 | 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. |
| 15731604 | 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. |
| 7577281 | 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. |
| 30378102 | 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. |
| 35882875 | 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. |
| 2286697 | 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. |
| 40074622 | 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. |
| 39625705 | 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. |
| 37333965 | 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. |
| 35653554 | 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. |
| 34116176 | 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. |
| 35035718 | 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. |
| 34559359 | 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. |
| 35185584 | 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. |
| 8768021 | 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. |
| 32415708 | 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. |
| 39347129 | 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. |
| 38589912 | 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. |
| 39400664 | 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. |