The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Study

NCT07089173 | Recruiting DMC

• 1 other identifier: 2025-112
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamics

Outcome Measures

Primary Outcomes (1)

• The 50% effective effect-site target concentration (EC₅₀) of remifentanil for suppressing patients' tracheal intubation response

  Through study completion, an average of 1 year.

Secondary Outcomes (2)

• 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

  Operative day, Postoperative day 1, Postoperative day 5.

Study Arms (3)

placebo group

PLACEBO COMPARATOR

Drug: Intravenous normal saline (NS 0.9)

sufentanil group

EXPERIMENTAL

Drug: intravenous sufentanil

lidocaine group

EXPERIMENTAL

Drug: Intravenous lidocaine

Interventions

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).

placebo group

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).

sufentanil group

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).

lidocaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective surgery under general anesthesia with endotracheal intubation;
• Classified as ASA physical status I-II.

You may not qualify if:

• Age \<18 years or \>65 years;
• 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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Related Publications (20)

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 21663812 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.

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• 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.

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• 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.

  PMID: 37380959 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.

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• 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.

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• 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.

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• 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.

  PMID: 19429669 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.

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• 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.

  PMID: 16211744 BACKGROUND

Study Officials

• Tao Luo

  Peking University Shenzhen Hospitai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhencong jiang

CONTACT

+8613148861770; jzcmichael@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)