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The aim of this study was to compare the effect-site target concentration (including EC₅₀ and EC₉₀) of remifentanil required to suppress cardiovascular responses to tracheal intubation during anesthesia induction with etomidate combined with either lidocaine or sufentanil.
This study is a single-center, randomized controlled trial utilizing a modified sequential method to determine the effect site target concentration of remifentanil, including the median effective concentration (EC₅₀) and the 90% effective concentration (EC₉₀). The study population consists of ASA class I-II patients undergoing general anesthesia with endotracheal intubation. Patients will be randomly assigned to one of three groups: placebo group, lidocaine group, and sufentanil group. Patients in each group will receive anesthesia induction with a combination of either saline, lidocaine, or sufentanil along with etomidate, followed by target-controlled infusion of remifentanil. The primary outcome measure is the median effective target concentration of remifentanil in the effect site (EC₅₀) for suppressing the intubation response. Secondary outcomes include the 90% effective target concentration of remifentanil (EC₉₀), changes in mean arterial pressure (MAP), heart rate (HR), and bispectral index (BIS) before and after intubation. Each group is expected to enroll 33 patients, totaling 99 patients across all three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo group | Placebo Comparator |
| |
| sufentanil group | Experimental |
| |
| lidocaine group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous normal saline (NS 0.9) | Drug | Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using placebo (normal saline) combined with etomidate (0.3 mg/kg). |
| Measure | Description | Time Frame |
|---|---|---|
| The 50% effective effect-site target concentration (EC₅₀) of remifentanil for suppressing patients' tracheal intubation response | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| The 90% effective effect-site target concentration (EC₉₀) of remifentanil for suppressing patients' tracheal intubation response | Through study completion, an average of 1 year. | |
| complications | including excessive hemodynamic fluctuations, hypoxemia, coughing during induction, etomidate-induced myoclonus, opioid-related chest wall rigidity, and postoperative nausea and vomiting (PONV). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhencong jiang | Contact | +8613148861770 | jzcmichael@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Luo | Peking University Shenzhen Hospitai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35743617 | Background | Lee IW, Schraag S. The Use of Intravenous Lidocaine in Perioperative Medicine: Anaesthetic, Analgesic and Immune-Modulatory Aspects. J Clin Med. 2022 Jun 20;11(12):3543. doi: 10.3390/jcm11123543. | |
| 10624998 | Background | Guignard B, Menigaux C, Dupont X, Fletcher D, Chauvin M. The effect of remifentanil on the bispectral index change and hemodynamic responses after orotracheal intubation. Anesth Analg. 2000 Jan;90(1):161-7. doi: 10.1097/00000539-200001000-00034. |
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| intravenous sufentanil | Drug | Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using sufentanil (0.2μg/kg) combined with etomidate (0.3 mg/kg). |
|
| Intravenous lidocaine | Drug | Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using lidocaine (1.5 mg/kg) combined with etomidate (0.3 mg/kg). |
|
| Operative day, Postoperative day 1, Postoperative day 5. |
| 22440314 | Background | Gelberg J, Jonmarker C, Stenqvist O, Werner O. Intravenous boluses of fentanyl, 1 mug kg(-)(1), and remifentanil, 0.5 mug kg(-)(1), give similar maximum ventilatory depression in awake volunteers. Br J Anaesth. 2012 Jun;108(6):1028-34. doi: 10.1093/bja/aes029. Epub 2012 Mar 22. |
| 33974096 | Background | Baldo BA. Toxicities of opioid analgesics: respiratory depression, histamine release, hemodynamic changes, hypersensitivity, serotonin toxicity. Arch Toxicol. 2021 Aug;95(8):2627-2642. doi: 10.1007/s00204-021-03068-2. Epub 2021 May 11. |
| 32566433 | Background | Trujillo C, Rudd D, Ogutcu H, Dong F, Wong D, Neeki M. Objective Characterization of Opiate-Induced Chest Wall Rigidity. Cureus. 2020 Jun 5;12(6):e8459. doi: 10.7759/cureus.8459. |
| 35819863 | Background | Oron AP, Souter MJ, Flournoy N. Understanding Research Methods: Up-and-down Designs for Dose-finding. Anesthesiology. 2022 Aug 1;137(2):137-150. doi: 10.1097/ALN.0000000000004282. |
| 21663812 | Background | Burlacu CL, McKeating K, McShane AJ. Remifentanil for the insertion and removal of long-term central venous access during monitored anesthesia care. J Clin Anesth. 2011 Jun;23(4):286-91. doi: 10.1016/j.jclinane.2010.12.007. |
| 38839427 | Background | Perez JJ, Strunk JD, Preciado OM, DeFaccio RJ, Chang LC, Mallipeddi MK, Deal SB, Oryhan CL. Effect of an opioid-free anesthetic on postoperative opioid consumption after laparoscopic bariatric surgery: a prospective, single-blinded, randomized controlled trial. Reg Anesth Pain Med. 2025 Sep 4;50(9):699-705. doi: 10.1136/rapm-2024-105632. |
| 15976218 | Background | Albertin A, Casati A, Federica L, Roberto V, Travaglini V, Bergonzi P, Torri G. The effect-site concentration of remifentanil blunting cardiovascular responses to tracheal intubation and skin incision during bispectral index-guided propofol anesthesia. Anesth Analg. 2005 Jul;101(1):125-30, table of contents. doi: 10.1213/01.ANE.0000153012.35120.FE. |
| 34061894 | Background | Misganaw A, Sitote M, Jemal S, Melese E, Hune M, Seyoum F, Sema A, Bimrew D. Comparison of intravenous magnesium sulphate and lidocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in elective surgical patients at Zewditu Memorial Hospital Addis Ababa, Ethiopia. PLoS One. 2021 Jun 1;16(6):e0252465. doi: 10.1371/journal.pone.0252465. eCollection 2021. |
| 28114177 | Background | Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available. |
| 23416718 | Background | Yeganeh N, Roshani B, Latifi H, Almasi A. Comparison of target-controlled infusion of sufentanil and remifentanil in blunting hemodynamic response to tracheal intubation. J Inj Violence Res. 2013 Jul;5(2):101-7. doi: 10.5249/jivr.v5i2.325. Epub 2013 Feb 15. |
| 11990278 | Background | Habib AS, Parker JL, Maguire AM, Rowbotham DJ, Thompson JP. Effects of remifentanil and alfentanil on the cardiovascular responses to induction of anaesthesia and tracheal intubation in the elderly. Br J Anaesth. 2002 Mar;88(3):430-3. doi: 10.1093/bja/88.3.430. |
| 21263301 | Background | Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5. |
| 19429669 | Background | Yoo KY, Jeong CW, Park BY, Kim SJ, Jeong ST, Shin MH, Lee J. Effects of remifentanil on cardiovascular and bispectral index responses to endotracheal intubation in severe pre-eclamptic patients undergoing Caesarean delivery under general anaesthesia. Br J Anaesth. 2009 Jun;102(6):812-9. doi: 10.1093/bja/aep099. Epub 2009 May 8. |
| 9640152 | Background | Thompson JP, Hall AP, Russell J, Cagney B, Rowbotham DJ. Effect of remifentanil on the haemodynamic response to orotracheal intubation. Br J Anaesth. 1998 Apr;80(4):467-9. doi: 10.1093/bja/80.4.467. |
| 18942248 | Background | Safavi M, Honarmand A. Attenuation of cardiovascular responses to laryngoscopy and tracheal intubation--intravenous sufentanil vs pethidine. Middle East J Anaesthesiol. 2008 Oct;19(6):1349-59. |
| 16211744 | Background | Kayhan Z, Aldemir D, Mutlu H, Ogus E. Which is responsible for the haemodynamic response due to laryngoscopy and endotracheal intubation? Catecholamines, vasopressin or angiotensin? Eur J Anaesthesiol. 2005 Oct;22(10):780-5. doi: 10.1017/s0265021505001298. |
| 39948474 | Result | Hao Z, Jiang Z, Li J, Luo T. The effect-site concentration of remifentanil blunting endotracheal intubation responses in elderly patients during anesthesia induction with etomidate: a dose-exploration study. BMC Anesthesiol. 2025 Feb 13;25(1):70. doi: 10.1186/s12871-024-02844-8. |
| 37380959 | Result | Jiang Z, Xiao J, Wang X, Luo T. The effect-site concentration of remifentanil blunting endotracheal intubation responses during anesthesia induction with etomidate: a dose-finding study. BMC Anesthesiol. 2023 Jun 28;23(1):225. doi: 10.1186/s12871-023-02165-2. |