← Back to Clinical Trials
Recruiting Phase 4 NCT07185074

Effect of Lidocaine Aerosol Plus Low-dose Cisatracurium vs Conventional-dose Cisatracurium on Intubation Conditions in ERCP - A Randomized Trial

Trial Parameters

Condition Intubation, Intratracheal
Sponsor Jiangang Song
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 188
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-01-17
Completion 2025-12-31
Interventions
Cisatracurium 0.05 mg/kg IVCisatracurium 0.15 mg/kg IVLidocaine aerosol 2.4% topical

Brief Summary

This clinical study investigates the effects of lidocaine aerosol as an adjunct to low-dose cisatracurium for endotracheal intubation during ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures. The aim is to assess whether lidocaine aerosol can improve the clinical conditions of intubation to a level comparable to the standard dose of cisatracurium, while reducing the amount of muscle relaxant required. The study also seeks to evaluate the impact of this approach on intubation success, extubation time, and recovery time in the operating room, ultimately improving the efficiency of the operating room. Participants will be randomly assigned to either the low-dose cisatracurium group with lidocaine aerosol or the standard-dose cisatracurium group. The primary outcome is the incidence of clinically acceptable intubation conditions, defined by the Cooper's grading system.

Eligibility Criteria

Inclusion Criteria: * Scheduled ERCP under general anesthesia requiring endotracheal intubation. * Hepatic dysfunction: Child-Pugh class B or C. * Age 18-70 years. * ASA physical status I-III. Exclusion Criteria: * Severe cardiovascular, cerebrovascular, or respiratory disease judged by investigators to increase risk. * Predicted difficult airway (e.g., Mallampati IV, mouth opening \<3 cm, limited neck extension). * Suspected gastrointestinal obstruction on preoperative assessment. * Cervical spine disease with limited neck mobility. * Child-Pugh class C with hepatic encephalopathy. * Neuromuscular disease. * Recurrent laryngeal nerve injury or vocal cord dysfunction. * Pregnancy or breastfeeding. * Known allergy/hypersensitivity to any study anesthetic (e.g., cisatracurium, lidocaine, propofol, remifentanil, or sufentanil). * Refusal to participate in the clinical trial.

Related Trials