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Patients undergoing elective surgery, aged 19 to 55 years, with ASA I or II, were selected for a sequential trial in two stages:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 | Other | In the first stage, Induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 of remifentanil were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method. |
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| Stage 2 | Other | In the second stage, the EC95 of remifentanil was fixed, and the EC50 and EC95 of ciprofol were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cipofol combined with remifentanil administered via target-controlled infusion | Drug | Cipofol combined with remifentanil administered via target-controlled infusion for inhibiting tracheal intubation stimulation in adults under qNOX pain index monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Half-effective concentration | Calculated using SPSS software based on the TCI target concentration set during anesthesia induction (the fixed value of the inducing dose does not change over time). | |
| Heart rate | 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). | |
| blood pressure | 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). | |
| CCS score (intubation score) | within 1 min while intubation (satisfactory intubation conditions simultaneously meet: visible laryngoscope exposure, no vocal cord movement, no coughing, relaxed jaw, no limb movement; otherwise, it is considered unsatisfactory intubation conditions) |
| Measure | Description | Time Frame |
|---|---|---|
| BIS index | 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). | |
| qNOX index | 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 洪桂平. 环泊酚靶控输注在口腔癌根治术中的应用[D]. 中南大学, 2023. | ||
| 40683805 | Background | Schuller PJ, Pretorius JPG, Newbery KB. Response of the Conox quantitative electroencephalographic monitor to neuromuscular block in awake volunteers. Br J Anaesth. 2025 Sep;135(3):660-667. doi: 10.1016/j.bja.2025.05.023. Epub 2025 Jul 18. | |
| 36618929 |
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for privacy protection
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Sequential method: Adjust the drug concentration for the next patient based on whether the previous case meets the conditions for inhibiting intubation stimulation
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| EMG index | 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
| Background |
| Wu B, Zhu W, Wang Q, Ren C, Wang L, Xie G. Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial. Front Pharmacol. 2022 Dec 21;13:1091579. doi: 10.3389/fphar.2022.1091579. eCollection 2022. |
| 34559359 | Background | 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. |
| 35035718 | Background | 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. |
| 39758227 | Background | Lan H, Liu S, Liao Y, Xu B, Lin Y, Wu X, Chen Q, Chen H, Guan X. EC50 and EC95 of Remifentanil for Inhibiting Bronchoscopy Responses in Elderly Patients During Fiberoptic Bronchoscopy Under Ciprofol Sedation: An Up-and-Down Sequential Allocation Trial. Drug Des Devel Ther. 2024 Dec 31;18:6487-6497. doi: 10.2147/DDDT.S490907. eCollection 2024. |
| 40220354 | Background | Vide S, Kreuzer M, Ferreira A, Couto M, Agusti M, Jaramillo S, Schneider G, Garcia PS, Abelha F, Amorim P, Troconiz I, Larson M, Gambus P. Cortical, subcortical, brainstem and autonomic responses to nociception under total intravenous anesthesia. J Clin Anesth. 2025 Apr;103:111825. doi: 10.1016/j.jclinane.2025.111825. Epub 2025 Apr 12. |
| 16492836 | Background | Kox WJ, von Heymann C, Heinze J, Prichep LS, John ER, Rundshagen I. Electroencephalographic mapping during routine clinical practice: cortical arousal during tracheal intubation? Anesth Analg. 2006 Mar;102(3):825-31. doi: 10.1213/01.ane.0000197776.26307.fa. |
| 31047645 | Background | Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30. |