How much remifentanil is needed to prevent blood pressure and heart-rate spikes during intubation with etomidate plus lidocaine or sufentanil

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

This will test what target concentration of remifentanil prevents blood pressure and heart-rate spikes during endotracheal intubation in adults having elective surgery with etomidate combined with either lidocaine or sufentanil.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking University Shenzhen Hospital (Academic / other)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07089173 on ClinicalTrials.gov

What this trial studies

This single-center randomized controlled trial uses a modified sequential method to find the effect-site target concentration of remifentanil (EC50 and EC90) that suppresses cardiovascular responses to tracheal intubation. ASA I–II adult patients undergoing elective general anesthesia with endotracheal intubation are randomized into three groups to receive saline, lidocaine, or sufentanil alongside etomidate for induction, followed by target-controlled infusion of remifentanil. The primary outcome is the median effective effect-site concentration (EC50) of remifentanil for blunting the intubation response, with secondary outcomes including EC90 and changes in mean arterial pressure, heart rate, and bispectral index around intubation. Each group plans to enroll about 33 patients for a total of 99 participants.

Who should consider this trial

Good fit: Adults aged 18–65 years with ASA physical status I–II, a BMI between 18.5 and 30 kg/m², and scheduled for elective surgery with planned endotracheal intubation are the intended participants.

Not a fit: Patients with significant cardiovascular or respiratory disease, difficult airway risk, BMI outside the 18.5–30 range, current use of chronic analgesics or beta-blockers, or those under 18 or over 65 are unlikely to benefit from these dosing results.

Why it matters

Potential benefit: If successful, the results could help anesthesiologists choose a remifentanil target concentration that better prevents hemodynamic spikes during intubation, improving safety during induction.

How similar studies have performed: Dose-finding studies of remifentanil for blunting intubation responses have produced reproducible EC50/EC90 estimates with other induction agents, though combinations using etomidate with lidocaine or sufentanil are less extensively characterized.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Tao Luo — Peking University Shenzhen Hospitai
• Study coordinator: zhencong jiang

Conditions Hemodynamics