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

RECRUITINGPhase 4Sponsored by Jiangang Song
Actively Recruiting
PhasePhase 4
SponsorJiangang Song
Started2025-01-17
Est. completion2025-12-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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.

Conditions2

Intubation, IntratrachealLiver Disease

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