Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07089173

Effect-site Concentration of Remifentanil to Suppress Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Trial

Led by Peking University Shenzhen Hospital · Updated on 2025-09-22

99

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect-site target concentration of remifentanil needed to suppress cardiovascular responses during tracheal intubation in patients undergoing general anesthesia. This randomized controlled trial includes patients classified as ASA physical status I-II, who are scheduled for elective surgery requiring endotracheal intubation. The study aims to compare remifentanil concentrations when combined with etomidate and either lidocaine or sufentanil, or a placebo, to understand how these combinations affect cardiovascular responses during anesthesia induction. Participants will be randomly assigned to one of three groups: a placebo group receiving normal saline with etomidate, a lidocaine group receiving lidocaine with etomidate, or a sufentanil group receiving sufentanil with etomidate. Each group will also receive a target-controlled infusion of remifentanil. The primary outcome is the median effective concentration of remifentanil (EC50) required to suppress the intubation response. Secondary outcomes include the 90% effective concentration (EC90) of remifentanil and measurements of mean arterial pressure, heart rate, and bispectral index before and after intubation. Participants will be monitored throughout the operative day and on postoperative days 1 and 5 for complications. Researchers will assess cardiovascular and anesthesia-related responses during and after intubation using clinical measurements. The study is expected to enroll a total of 99 patients across all groups. The participation period includes anesthesia induction, intubation, and short-term postoperative monitoring, with data collection continuing through study completion, approximately one year after enrollment begins.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective surgery under general anesthesia with endotracheal intubation
  • Classified as ASA physical status I-II
  • Aged between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 65 years
  • Body mass index (BMI) over 30 kg/m² or under 18.5 kg/m²
  • Diagnosis of hypertension or severe cardiovascular diseases such as myocardial infarction, heart failure, atrial fibrillation, atrioventricular block, or moderate-to-severe valvular diseases
  • Diagnosis of respiratory diseases including acute exacerbation of chronic obstructive pulmonary disease, acute respiratory distress syndrome, acute asthma attack, moderate-to-severe pulmonary hypertension, or severe pneumonia
  • Diagnosis of obstructive sleep apnea syndrome or history of difficult intubation or anticipated difficult airway
  • Renal, hepatic, or hematologic diseases
  • High risk of aspiration or reflux
  • Current use of analgesics for chronic pain or beta-blockers for cardiovascular diseases
  • Current use of psychotropic medications
  • Contraindications to remifentanil or sufentanil such as known hypersensitivity, use of monoamine oxidase inhibitors, myasthenia gravis, or conditions causing respiratory depression
  • Contraindications to lidocaine including allergy to local anesthetics, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe cardiac conduction block

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single anesthesia induction session

Participants receive anesthesia induction with either placebo (normal saline), lidocaine, or sufentanil combined with etomidate, along with a target-controlled infusion of remifentanil to suppress intubation responses.

1 visit (in-person)

Follow-up

Duration - 6 days

Participants are monitored for complications on the operative day and postoperative days 1 and 5.

3 visits (in-person)

Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Actively Recruiting

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Research Team

Z

zhencong jiang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Intravenous boluses of fentanyl, 1 μg kg⁻¹, and remifentanil, 0.5 μg kg⁻¹, give similar maximum ventilatory depression in awake volunteers.

J Gelberg, C Jonmarker, O Stenqvist...

https://pubmed.ncbi.nlm.nih.gov/22440314

Effect of an opioid-free anesthetic on postoperative opioid consumption after laparoscopic bariatric surgery: a prospective, single-blinded, randomized controlled trial.

Josiah Joco Perez, Joseph D Strunk, Octavio M Preciado...

https://pubmed.ncbi.nlm.nih.gov/38839427

The effect-site concentration of remifentanil blunting cardiovascular responses to tracheal intubation and skin incision during bispectral index-guided propofol anesthesia.

Andrea Albertin, Andrea Casati, Lombardo Federica...

https://pubmed.ncbi.nlm.nih.gov/15976218

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.

Abebaw Misganaw, Mulualem Sitote, Suliman Jemal...

https://pubmed.ncbi.nlm.nih.gov/34061894