The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Study
NCT ID: NCT07089173
Last Updated: 2025-09-22
Study Results
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Basic Information
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RECRUITING
NA
99 participants
INTERVENTIONAL
2025-08-01
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo group
Intravenous normal saline (NS 0.9)
Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using placebo (normal saline) combined with etomidate (0.3 mg/kg).
sufentanil group
intravenous sufentanil
Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using sufentanil (0.2μg/kg) combined with etomidate (0.3 mg/kg).
lidocaine group
Intravenous lidocaine
Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using lidocaine (1.5 mg/kg) combined with etomidate (0.3 mg/kg).
Interventions
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Intravenous normal saline (NS 0.9)
Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using placebo (normal saline) combined with etomidate (0.3 mg/kg).
intravenous sufentanil
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
Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using lidocaine (1.5 mg/kg) combined with etomidate (0.3 mg/kg).
Eligibility Criteria
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Inclusion Criteria
* Classified as ASA physical status I-II.
Exclusion Criteria
* Body mass index (BMI) \>30 kg/m² or \<18.5 kg/m²;
* Diagnosis of hypertension or severe cardiovascular diseases (including myocardial infarction, heart failure, atrial fibrillation, atrioventricular block, moderate-to-severe valvular diseases) or respiratory diseases (including acute exacerbation of chronic obstructive pulmonary disease, acute respiratory distress syndrome, acute asthma attack, moderate-to-severe pulmonary hypertension, severe pneumonia);
* Diagnosis of obstructive sleep apnea syndrome or history of difficult intubation or preoperatively anticipated difficult airway;
* Renal, hepatic or hematologic diseases;
* High risk of aspiration or reflux;
* Current use of analgesics for chronic pain or β-blockers for cardiovascular diseases;
* Current use of psychotropic medications;
* Contraindications to remifentanil or sufentanil, including: known hypersensitivity to any component of these drugs or other fentanyl analogues, current use of monoamine oxidase inhibitors, myasthenia gravis or conditions predisposing to respiratory depression, bronchial asthma or related disorders;
* Contraindications to lidocaine, including: known allergy to local anesthetics, concurrent Adams-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe cardiac conduction block.
18 Years
65 Years
ALL
No
Sponsors
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Peking University Shenzhen Hospital
OTHER
Responsible Party
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Principal Investigators
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Tao Luo
Role: PRINCIPAL_INVESTIGATOR
Peking University Shenzhen Hospitai
Locations
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.
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.
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.
Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.
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.
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.
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.
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.
Other Identifiers
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2025-112
Identifier Type: -
Identifier Source: org_study_id
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