Status:
RECRUITING
Effect of Lidocaine Aerosol Plus Low-dose Cisatracurium vs Conventional-dose Cisatracurium on Intubation Conditions in ERCP - A Randomized Trial
Lead Sponsor:
Jiangang Song
Conditions:
Intubation, Intratracheal
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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) proce...
Detailed Description
Retrospective registration note. Enrollment began on January 17, 2025, was temporarily paused due to investigator training, and is being reactivated at the time of registration. No changes were made t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT07185074
Start Date
January 17 2025
End Date
December 31 2025
Last Update
September 22 2025
Active Locations (1)
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1
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 201203