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

ConditionHemodynamics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University Shenzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective surgery under general anesthesia with endotracheal intubation;

Classified as ASA physical status I-II.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

  • 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).

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: placebo groupPlacebo comparator 1 intervention
Group B: sufentanil groupExperimental treatment 1 intervention
Group C: lidocaine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, an average of 1 year.

Secondary outcomes

1

The 90% effective effect-site target concentration (EC₉₀) of remifentanil for suppressing patients' tracheal intubation response

Time frame
Through study completion, an average of 1 year.
2

complications

including excessive hemodynamic fluctuations, hypoxemia, coughing during induction, etomidate-induced myoclonus, opioid-related chest wall rigidity, and postoperative nausea and vomiting (PONV).

Time frame
Operative day, Postoperative day 1, Postoperative day 5.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Shenzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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