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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo group

Group Type PLACEBO_COMPARATOR

Intravenous normal saline (NS 0.9)

Intervention Type DRUG

Under target-controlled infusion (TCI) of remifentanil, anesthesia induction is performed using placebo (normal saline) combined with etomidate (0.3 mg/kg).

sufentanil group

Group Type EXPERIMENTAL

intravenous sufentanil

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Intravenous lidocaine

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University Shenzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tao Luo

Role: PRINCIPAL_INVESTIGATOR

Peking University Shenzhen Hospitai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

zhencong jiang

Role: CONTACT

+8613148861770

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhencong Jiang

Role: primary

+8613148861770

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35743617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10624998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22440314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33974096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32566433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35819863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21663812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38839427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39948474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37380959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15976218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34061894 (View on PubMed)

Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.

Reference Type BACKGROUND
PMID: 28114177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23416718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11990278 (View on PubMed)

Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.

Reference Type BACKGROUND
PMID: 21263301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19429669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9640152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18942248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16211744 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.